Pure Global

Spiggle & Theis SpeedSurg Micro Drill and Shaver System - HSA Registration DE0507692

Access comprehensive regulatory information for Spiggle & Theis SpeedSurg Micro Drill and Shaver System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507692 and owned by Spiggle & Theis Medizintechnik GmbH. The device was registered on January 13, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0507692
Spiggle & Theis SpeedSurg Micro Drill and Shaver System
HSA Registration Number: DE0507692
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Micro drill and shaver system that drives an electronic motor (accessory) for drilling and cutting bones and for shaver treatment in the field of ENT or head and neck surgery. The electronic motor is used for the operation of handpieces (and the instruments used in combination with these). Indicated for interventions at the petrous bone (drilling work), interventions at the visceral cranium (sawing), interventions at the paranasal sinuses (FESS) using the shaver and interventions at the stapes foot plate using the Stapes-Drill (low-speed area only).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0507692
Registration Date
January 13, 2023
Retention Due Date
January 12, 2026
Product Owner
Short Name
Spiggle & Theis Medizintechnik GmbH
Address
Burghof 14, 51491 Overath, GERMANY
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model Information
Model Name(s)
Lowspeed Drill Handpiece, Straight Lowspeed Drill Handpiece, Angled LowSpeed Electronic Motor (SpeedSurg) Clips, small, for attaching, cooling hose to motorcable, 10 pieces Clips, large, for attaching, hose to handpiece, 3 pieces Cooling tube for handpieces, 77HG002 + 77HW001, short, 4 cm, Cooling tube for handpiece, 77HW002, Cooling tube for handpieces, 77HG004 + 77HW003, 1 piece Cooling tube for handpieces, 77HG002 + 77HW001, long, 5,25 cm, Cooling tube for handpieces, 77HG002 + 77HW001, flexible, (drops), long, 5.25 cm CI-HighSpeed Drill Handpiece angled SpeedSurg, control unit, for Micro Drill and Shaver System, 80.000 rpm Foot pedal Vario IPX8, for micro drill and shaver system, SpeedSurg HighSpeed Drill Handpiece straight HighSpeed Drill Handpiece angled HighSpeed Electronic Motor (SpeedSurg) Shaver blade, Agressive full radius, straight, 3.5 mm, disposable Shaver blade, Spike cutter, straight, 3.5 mm, disposable Shaver blade, Spike cutter, concave 15°, 3.5 mm, disposable Shaver blade, Spike cutter, convex 15°, 3.5 mm, disposable Shaver blade, Spike cutter, concave 40°, 3.5 mm, disposable Shaver blade, Spike cutter, concave 60°, 3.5 mm, disposable Shaver blade, Agressive full radius, straight, 4.0 mm, disposable Shaver blade, Agressive full radius, concave 60°, 4.0 mm, disposable Shaver blade, Spike cutter, straight, 4.0 mm, disposable Shaver blade, Spike cutter, concave 15°, 4.0 mm, disposable Shaver blade, Spike cutter, convex 15°, 4.0 mm, disposable Shaver blade, Spike cutter, concave 40°, 4.0 mm, disposable Shaver blade, Spike cutter, convex 40°, 4.0 mm, disposable Shaver blade, Spike cutter, concave 60°, 4.0 mm, disposable Shaver blade, Spike cutter, convex 60°, 4.0 mm, disposable Shaver blade, Agressive full radius, straight, 4.5 mm, disposable Shaver blade, Spike cutter, straight, 4.5 mm, disposable Shaver blade, Rhino Diamond Burr, concave 15°, 3.5 mm, disposable Shaver blade, Rhino Rose Burr, straight, 3.5 mm, disposable Shaver blade, Rhino Rose Burr, concave 15°, 3.5 mm, disposable Shaver blade, Rhino Rose Burr, concave 60°, 3.5 mm, disposable Shaver blade, Rhino Cylindrical Burr, concave 60°, 3.5 mm, disposable ENT Shaver handpiece, angled, SpeedSurg, Set, Micro Drill and Shaver System, 80.000 rpm Tripod for cooling agent, for SpeedSurg, Irrigation set, for cooling agent, sterile, 10 pieces/box Lindemann cuter, carbide, LowSpeed Lindemann cuter, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, LowSpeed Bur, carbide, cross-cut, LowSpeed Bur, carbide, cross-cut, LowSpeed Bur, carbide, cross-cut, LowSpeed Bur, carbide, cross-cut, LowSpeed Bur, carbide, cross-cut, LowSpeed Bur, carbide, cross-cut, LowSpeed Lindemann cuter, carbide, LowSpeed Lindemann cuter, carbide, LowSpeed Osteotomy bur, carbide, oval head Ø 4.0 mm, length 70 mm,, 8 blades, unsterile, 1 piece Osteotomy bur, carbide, oval head Ø 5.5 mm, length 70 mm,, 10 blades, unsterile, 1 piece Bur, carbide, A-toothing, LowSpeed Bur, carbide, A-toothing, LowSpeed Bur, carbide, A-toothing, LowSpeed Bur, carbide, A-toothing, LowSpeed Bur, carbide, A-toothing, LowSpeed Bur, carbide, A-toothing, LowSpeed Bur, carbide, A-toothing, LowSpeed Bur, carbide, A-toothing, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, extra coarse grain, LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, medium grain. LowSpeed Diamond bur, HighSpeed, length I, head diameter 3.1 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 3.1 mm, medium grain, steril, reusable Diamond bur, HighSpeed, length I, head diameter 4.0 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 4.0 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 5.0 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 5.0 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 6.0 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 6.0 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 0.4 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 0.4 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 0.6 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 0.6 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 0.8 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 0.8 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 1.0 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 1.0 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 1.4 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 1.4 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 1.8 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 1.8 mm, medium grain, sterile, reusable Diamond bur, HighSpeed, length I, head diameter 2.3 mm, medium grain, sterile Diamond bur, HighSpeed, length I, head diameter 2.3 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI93, head diameter 0.6 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI93, head diameter 0.8 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI93, head diameter 1.2 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI93, head diameter 1.7 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI93, head diameter 2.3 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI, head diameter 2.7 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI, head diameter 3.1 mm, medium grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI, head diameter 4.0 mm, medium grain, sterile, reusable Cylinder, Diamond, CI-HighSpeed, length CI93, head diameter 0.6 mm, medium grain, sterile, reusable Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, super coarse grain, HighSpeed Diamond bur, CI-HighSpeed, length CI, head diameter 3.1 mm, super-coarse grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI, head diameter 4.0 mm, super-coarse grain, sterile, reusable Diamond bur, CI-HighSpeed, length CI, head diameter 5.0 mm, super-coarse grain, sterile, reusable Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, HighSpeed Bur, steel, A-toothing, CI-HighSpeed Bur, steel, A-toothing, CI-HighSpeed Bur, steel, A-toothing, CI-HighSpeed Bur, steel, A-toothing, CI-HighSpeed Bur, steel, A-toothing, CI-HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, HighSpeed Bur, carbide, CI-HighSpeed Bur, carbide, CI-HighSpeed Bur, carbide, CI-HighSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, cross-cut, LowSpeed Bur, steel, A-toothing, LowSpeed Bur, steel, A-toothing, LowSpeed Bur, steel, A-toothing, LowSpeed Bur, steel, A-toothing, LowSpeed Bur, steel, A-toothing, LowSpeed Bur, steel, A-toothing, LowSpeed
Model Identifier(s)
77HG002 77HW001 77MM010 77ZZC01 77ZZC02 77ZZS03 77ZZS04 77ZZS05 77ZZS06 77ZZS06-B 78CI1080 78CU80-EN 78FS01 78HG1070 78HW1070 78MM08003 78SB100 78SB130 78SB131-C 78SB131-CEX 78SB134-C 78SB136-C 78SB200 78SB206-CEX 78SB230 78SB231-C 78SB231-CEX 78SB234-C 78SB234-CEX 78SB236-C 78SB236-CEX 78SB300 78SB330 78SBO1D1 78SBO1R0 78SBO1R1 78SBO1R6 78SBO1W6 78SH00 78SS80-SET-EN 78ST45 78ZS07 CR065051604 CR065052104 CR070010506 CR070010806 CR070011006 CR070011206 CR070011406 CR070011606 CR070011806 CR070012106 CR070012306 CR070012708 CR070013108 CR070013508 CR070014010 CR070014510 CR070015008 CR070015012 CR070016008 CR070016014 CR070016508 CR070017016 CR070021410 CR070022312 CR070023112 CR070024014 CR070025014 CR070026016 CR070051604 CR070052104 CR070074008 CR070075510 CR070221010 CR070221410 CR070222310 CR070223110 CR070223510 CR070224012 CR070225014 CR070226016 DR070010691 DR070010791 DR070010891 DR070011090 DR070011091 DR070011291 DR070011491 DR070011691 DR070011891 DR070012190 DR070012191 DR070012391 DR070012393 DR070012591 DR070012791 DR070012793 DR070012991 DR070013191 DR070013193 DR070013591 DR070013593 DR070014091 DR070014093 DR070014591 DR070014593 DR070015091 DR070015093 DR070016090 DR070016091 DR070016093 DR070017091 DR070017093 DR070074091 DR070132091 HSDMD7431 HSDMD7431X HSDMD7440 HSDMD7440X HSDMD7450 HSDMD7450X HSDMD7460 HSDMD7460X HSDMD7604 HSDMD7604X HSDMD7606 HSDMD7606X HSDMD7608 HSDMD7608X HSDMD7610 HSDMD7610X HSDMD7614 HSDMD7614X HSDMD7618 HSDMD7618X HSDMD7623 HSDMD7623X HSDMDCI06X HSDMDCI08X HSDMDCI12X HSDMDCI17X HSDMDCI23X HSDMDCI27X HSDMDCI31X HSDMDCI40X HSDMZCI06X HSDR27431 HSDR27431X HSDR27440 HSDR27440X HSDR27450 HSDR27450X HSDR27460 HSDR27460X HSDR27623 HSDR27623X HSDSGCI31X HSDSGCI40X HSDSGCI50X HSSMA7431 HSSMA7431X HSSMA7440 HSSMA7440X HSSMA7450 HSSMA7450X HSSMA7460 HSSMA7460X HSSMACI23X HSSMACI31X HSSMACI40X HSSMACI50X HSSMACI60X HST740831 HST740831X HST741040 HST741040X HST741250 HST741250X HST741460 HST741460X HST760605 HST760605X HST760608 HST760608X HST760610 HST760610X HST760614 HST760614X HST760618 HST760618X HST760623 HST760623X HSTCI1431X HSTCI1440X HSTCI1450X SR070010606 SR070010806 SR070011006 SR070011408 SR070011808 SR070012308 SR070012710 SR070013106 SR070013110 SR070013506 SR070013512 SR070014012 SR070014512 SR070015008 SR070015012 SR070016014 SR070017016 SR070074010 SR070075012 SR070076014 SR070084010 SR070086014 SR070087016 SR070088016 SR070095012 SR070096014 SR070098016 SR070124010 SR070126014 SR070128016 SR070222310 SR070223110 SR070223510 SR070224012 SR070225014 SR070226016