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DIROS OWLยฎ Universal RF System - HSA Registration DE0510499

Access comprehensive regulatory information for DIROS OWLยฎ Universal RF System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510499 and owned by Diros Technology Inc.. The device was registered on March 25, 2025.

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.

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CLASS D
DE0510499
DIROS OWLยฎ Universal RF System
HSA Registration Number: DE0510499
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Product Description

Radio Frequency (R.F) lesioning during neurosurgical and interventional pain management procedures

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0510499
Registration Date
March 25, 2025
Retention Due Date
March 24, 2026
Product Owner
Short Name
Diros Technology Inc.
Address
120 Gibson Drive, Markham, Ontario, L3R2Z3, CANADA
Registrant
Address
101 THOMSON ROAD, UNITED SQUARE, #17-03, SINGAPORE 307591
Importer
Address
101 THOMSON ROAD, UNITED SQUARE, #17-03, SINGAPORE 307591
Model Information
Model Name(s)
CABLE FOR URF-3AP WITH CLAMP TO OWL GD-PAD NON-CORDED OWL GASSERIAN GANGLION STRAIGHT LESION ELECTRODE/R.F.PROBE (TCH) OWL GASSERIAN GANGLION CURVED LESION ELECTRODE/R.F.PROBE (TCH) OWL GASSERIAN GANGLION SET, with STRAIGHT &CURVED LESION ELECTRODES (Thermocouple) OWL GASSERIAN GANGLION SET (Thermocouple) GASSERIAN GANGLION R.F.PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO BIPOLAR DXE CABLE FOR URF-3APTO BIPOLAR HYBRID CANNULA or OWL DISPOSABLE THERMOCOUPLE RF PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO BIPOLAR THERMOCOUPLE R.F.PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO BIPOLAR RE-USABLE TCH PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO discTRODE AND NON-RF PROBE CABLE FOR URF-3AP TO DXE/ DST CABLE FOR URF-3AP TO 4 DXE/ DST CABLE FOR URF-3AP TO HYBRID CANNULA OR THERMOCOUPLE DISPOSABLE RF PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO R.F. PROBE (NOTEMPERATURESENSING) CABLE FOR URF-3AP TO 4 R.F. PROBES (NO TEMPERATURESENSING) CABLE FOR URF-3AP TO PASHA CATHโ„ขCATHETER CABLE FOR URF-3AP TO SPINECATH CABLE FOR URF-3AP TO THERMOCOUPLE R.F.PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO RE-USABLE TCH PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO THERMISTOR R.F.PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO TASKER THALAMOTOMY STIMULATING ELECTRODE OWL FACET DENERVATION THERMOCOUPLE R.F.PROBE/TEMPERATURE SENSOR, 15CM OWL (16Ga.) SHARP CURVED RFInsulated Cannula OWL (16Ga.) SHARP CURVED RF Insulated Cannula OWL (16Ga.) SHARP CURVED RF Insulated Cannula OWL (16Ga.) SHARP CURVED RF Insulated Cannula OWL (18Ga.) RF Insulated Cannula OWL (18Ga.) SHARP CURVED RF Insulated Cannula OWL (18Ga.) RF Insulated Cannula OWL (18Ga.) RF Insulated Cannula OWL (18Ga.) BLUNT CURVED RF Insulated Cannula OWL (18Ga.) SHARP CURVED RF Insulated Cannula OWL (18Ga.) RF Insulated Cannula OWL (18Ga.) SHARP CURVED RF Insulated Cannula OWL (18Ga.) RF Insulated Cannula OWL FACET DENERVATION THERMOCOUPLE R.F.PROBE/TEMPERATURE SENSOR, 20CM OWL (20Ga.) RF Insulated Cannula OWL (20Ga.) BLUNTCURVED RF Insulated Cannula OWL (20Ga.) SHARP CURVED RF Insulated Cannula OWL (20Ga.) RF Insulated Cannula OWL (20Ga.) BLUNT CURVED RF Insulated Cannula OWL (20Ga.) SHARP CURVED RF Insulated Cannula OWL (20Ga.) RF Insulated Cannula OWL (20Ga.) BLUNT CURVED RF Insulated Cannula OWL (20Ga.) SHARP CURVED RF Insulated Cannula OWL (20Ga.) RF Insulated Cannula OWL (20Ga.) BLUNT CURVED RF Insulated Cannula OWL (20Ga.) SHARP CURVED RF Insulated Cannula OWL (20Ga.) RF Insulated Cannula OWL (20Ga.) SHARP CURVED RF Insulated Cannula OWL (20Ga.) RF Insulated Cannula OWL (20Ga.) SHARP CURVED RF Insulated Cannula OWL (20Ga.) SHARP CURVED RF Insulated Cannula OWL (20Ga.) RF Insulated Cannula OWL (21Ga.) RF Insulated Cannula OWL (21Ga.) RF Insulated Cannula OWL FACET DENERVATION SET(15CM) (Thermocouple) OWL FACET DENERVATION SET(20CM) (Thermocouple) OWL FACET DENERVATION THERMOCOUPLE R.F.PROBE/TEMPERATURE SENSOR, 5CM OWL FACET DENERVATION THERMOCOUPLE R.F.PROBE/TEMPERATURE SENSOR , 10CM OWL (22Ga.) RF Insulated Cannula OWL (22Ga.) BLUNT CURVED RF Insulated Cannula OWL (22Ga.) SHARP CURVED RF Insulated Cannula OWL (22Ga.) RF Insulated Cannula OWL (22Ga.) SHARP CURVED RF Insulated Cannula OWL (22Ga.) RF Insulated Cannula OWL (22Ga.) BLUNT CURVED RF Insulated Cannula OWL (22Ga.) SHARP CURVED RF Insulated Cannula OWL (22Ga.) RF Insulated Cannula OWL (22Ga.) SHARP CURVED RF Insulated Cannula OWL (22Ga.) RF Insulated Cannula OWL (22Ga.) RF Insulated Cannula OWL (22Ga.) SHARP CURVED RF Insulated Cannula OWL (22Ga.) RF Insulated Cannula OWL (22Ga.) BLUNT CURVED RF Insulated Cannula OWL (22Ga.) SHAR PCURVED RF Insulated Cannula OWL FACET DENERVATION SET(5CM) (Thermocouple) OWL FACET DENERVATION SET(10CM) (Thermocouple) DIROS ADAPTER FOR URF-1(IEC), URF-2A, URF-2AP TO FIT OWLโ„ข GD-PAD CORDED CABLE WITH 4MM BANANA PIN AND CLAMP (FOR COSMAN, NEUROTHERM, RADIONICS, STRYKER, & SMITH& NEPHEW RFDEVICES) TO OWL GD-PAD NON-CORDED 6 INCH CABLE FOR URF-3AP TO BIPOLAR TCH PROBE/TEMPERATURE SENSOR 8FT 6 INCH CABLE FOR URF-3AP TO TCH PROBE/TEMPERATURE SENSOR 8FT 6 INCH CABLE FOR BAYLIS MULTI-LESION MODULE TO OWL RE-USABLE THERMOCOUPLE RFPROBE/TEMPERATURE SENSOR TCH 6 INCH CABLE FOR BAYLIS TO OWL RE-USABLE THERMOCOUPLE RF PROBE/TEMPERATURE SENSOR TCH 6 INCH CABLE FOR COSMAN TO OWL RE-USABLE THERMOCOUPLE RFPROBE/TEMPERATURE SENSOR TC 6 INCH CABLE FOR NEUROTHERM TO OWL RE-USABLE THERMOCOUPLE RFPROBE/TEMPERATURE SENSOR TCH 6 INCH ADAPTER CABLE FROM ALLIGATOR TO DXE/DST CANNULA CUSTOM CARRYING CASE FOR URF-3AP PLASTIC FOOTSWITCH FOR URF-3AP CABLE FOR URF-3AP TO BIPOLAR THERMOCOUPLE RF PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO OWL DISPOSABLE TC RF PROBE AND NON-RF PROBE/TEMPERATURE SENSOR CABLE FOR URF-3AP TO OWL DISPOSABLE TC RFP ROBE AND NON-RF PROBE/TEMPERATURE SENSOR CUSTOM DIROS ADAPTER (4MM BANANA PIN TO OWL GD-PAD CORDED) FORCOSMAN,NEUROTHERM,RADIONICS,STRYKER, & SMITH& NEPHEW RFDEVICES INTERMEDIATE CABLE FOR BAYLIS MULTI-LESION MODULE TO OWL RE-USABLE TC PROBE/TEMPERATURE SENSOR INTERMEDIATE CABLE FOR BAYLIS MULTI-LESION MODUEL TO OWL DISPOSABLE THERMOCOUPLE RFPROBE/TEMPERATURE SENSOR ORDIROS OWL HYBRID INTERMEDIATE CABLE FOR BAYLIS MULTI-LESION MODULE TO OWL RE-USABLE TCH PROBE/TEMPERATURE SENSOR INTERMEDIATECABLE FOR BAYLIS TO OWL DISPOSABLE THERMOCOUPLE RF PROBE/TEMPERATURE SENSOR ORDIROS OWL HYBRID INTERMEDIATE CABLE FOR BAYLIS TO OWL RE-USABLE TCH PROBE/TEMPERATURE SENSOR CABLE FOR COSMAN TO DXE/DST CABLE FOR COSMAN TO 4 DXE/DST INTERMEDIATE CABLE FOR COSMAN TO OWL RE-USABLE TC PROBE/TEMPERATURE SENSOR INTERMEDIATE CABLE FOR COSMAN TO OWL DISPOSABLE THERMOCOUPLE RF PROBE/TEMPERATURE SENSOR ORDIROS OWL HYBRID INTERMEDIATE CABLE FOR COSMANTO OWL RE-USABLE TCH PROBE/TEMPERATURE SENSOR CABLE FOR NEUROTHERM TODXE/DST CABLE FOR NEUROTHERM TO 4DXE/DST INTERMEDIATECABLE FORNEUROTHERM TO OWL RE-USABLE TCPROBE/TEMPERATURE SENSOR INTERMEDIATE CABLE FOR NEUROTHERM TO OWL DISPOSABLE THERMOCOUPLE RF PROBE/TEMPERATURE SENSOR ORDIROS OWL HYBRID INTERMEDIATE CABLE FOR NEUROTHERM TO OWL RE-USABLE TCH PROBE/TEMPERATURE SENSOR OWL (18 Ga.)GASSERIANGANGLION RFINSULATED CANNULA OWL GASSERIAN GANGLION STRAIGHT RF PROBE/TEMPERATURE SENSOR OWL GASSERIAN GANGLION CURVED RF PROBE/TEMPERATURE SENSOR OWL GASSERIAN GANGLION RF PROBE/TEMPERATURE SENSOR OWL GASSERIAN GANGLION RF PROBE/TEMPERATURE SENSOR OWL (19 Ga.) GASSERIAN GANGLION RF INSULATED CANNULA STERILE SINGLE USE DISPOSABLE PROBE TEST ADAPTERS OWL RF PROBE/TEMPERATURE SENSOR (15cm) OWL RF PROBE/ TEMPERATURE SENSOR (20cm) OWL RF PROBE/TEMPERATURE SENSOR (5cm) OWL RF PROBE/TEMPERATURE SENSOR (10cm) OWL GD-PADPATIENT RETURN ELECTRODE OWL GD-PADPATIENT RETURN ELECTRODE OWL (18Ga.) RF INSULATED HYBRID CANNULA OWL (18Ga.) SHARP CURVED RF INSULATED HYBRID CANNULA OWL (18Ga.) RF INSULATED HYBRID CANNULA OWL (18Ga.) SHARP CURVED RF INSULATED HYBRID CANNULA OWL (20Ga.) BLUNT CURVED RF INSULATED HYBRID CANNULA OWL (20Ga.) SHARP CURVED RF INSULATED HYBRID CANNULA OWL (20Ga.) RF INSULATED HYBRID CANNULA OWL (20Ga.) BLUNT CURVED RF INSULATED HYBRID CANNULA OWL (20Ga.) RF INSULATED HYBRID CANNULA OWL (20Ga.) BLUNT CURVED RF INSULATED HYBRID CANNULA OWL (20Ga.) SHARP CURVED RF INSULATED HYBRID CANNULA OWL (20Ga.) RF INSULATED HYBRID CANNULA OWL (22Ga.) RF INSULATED HYBRID CANNULA OWL (22Ga.) SHARP CURVED RF INSULATED HYBRID CANNULA OWL (22Ga.) RF INSULATED HYBRID CANNULA OWL (22Ga.) RF INSULATED HYBRID CANNULA OWL (22Ga.) RF INSULATED HYBRID CANNULA OWL (22Ga.) DRC CANNULA OWL (22Ga.) DRC CANNULA OWL (22Ga.) DRC CANNULA TRIDENTTM RF INSULATED CANNULA (FOR USE WITH 10CM RF PROBE) TRIDENTTM RF INSULATED CANNULA (FOR USE WITH 10CM RF PROBE) TRIDENTTM RF INSULATED CANNULA (FOR USE WITH 15CM RF PROBE) TRIDENTTM RF INSULATED CANNULA (FOR USE WITH 15CM RF PROBE) TRIDENTTM RF INSULATED CANNULA (FOR USE WITH 5CM RF PROBE) TRIDENTTM RF INSULATED CANNULA (FOR USE WITH 5CM RF PROBE) OWL (22Ga.) DXE CANNULA OWL (22Ga.) DXE CANNULA OWL (23Ga.) DXE CANNULA OWL (23Ga.) DXE CANNULA OWL (23Ga.) DXE CANNULA SET OF 4, INTERMEDIATE CABLES FOR MLA-4 TO RE-USABLE TCH PROBES/TEMPERATURE SENSORS SET OF 4, ADAPTER CABLES FOR MLA-4 TO TC PROBES SET OF 4, ADAPTER CABLES FOR MLA-4 TO TC RE-USABLE PROBES/TEMPERATURE SENSORS SET OF 4, ADAPTER CABLES FOR MLA-4 TO HYBRIDC ANNULAE OR DISPOSABLE TCP ROBES/TEMPERATURE SENSORS MULTI-LESION ADAPTOR OWL UNIVERSAL RF SYSTEM
Model Identifier(s)
3AP-CL 462-003-TCH-S 462-004-TCH-S 462-100-TC-S 463-001-TC-S 463-002-TCH-S 463-103-BPDXE-S 463-103-BPHCT-S 463-103-BPTC-S 463-103-BPTCH-S 463-103-DT-S 463-103-DXE-S 463-103-DXE4-S 463-103-HCT-S 463-103-NT-S 463-103-NT4-S 463-103-PS-S 463-103-SC-S 463-103-TC-S 463-103-TCH-S 463-103-TM-S 463-104-TS-S 466-015-TCH-S 466-016/100/10-SC 466-016/100/6-SC 466-016/150/10-SC 466-016/150/6-SC 466-018/100/10 466-018/100/10-SC 466-018/100/15 466-018/100/5 466-018/100/5-BC 466-018/100/5-SC 466-018/150/10 466-018/150/10-SC 466-018/54/10 466-020-TCH-S 466-020/100/10 466-020/100/10-BC 466-020/100/10-SC 466-020/100/5 466-020/100/5-BC 466-020/100/5-SC 466-020/150/10 466-020/150/10-BC 466-020/150/10-SC 466-020/150/15 466-020/150/15-BC 466-020/150/15-SC 466-020/150/5 466-020/150/5-SC 466-020/200/10 466-020/200/10-SC 466-020/200/20-SC 466-020/200/5 466-021/100/5 466-021/50/4 466-150-TC-S 466-200-TC-S 467-005-TCH-S 467-010-TCH-S 467-022/100/10 467-022/100/10-BC 467-022/100/10-SC 467-022/100/2 467-022/100/2-SC 467-022/100/5 467-022/100/5-BC 467-022/100/5-SC 467-022/150/10 467-022/150/10-SC 467-022/150/5 467-022/54/10 467-022/54/10-SC 467-022/54/4 467-022/54/5-BC 467-022/54/5-SC 467-050-TC-S 467-100-TC-S 473-002-S 4BAN-CL 6-463-103-BPTCH-S 6-463-103-TCH-S 6-CB2D-04-TCH-S 6-CB2D-14-TCH-S 6-CC2D-04-TCH-S 6-CN2D-04-TCH-S 6-NT-DXE-S 653-200 653-447 C463-103-BPTC-S C463-103-DT-S C463-103-DT-S2F-S C473-004-S CB2D-04-R3M-S CB2D-04-S2F-S CB2D-04-TCH-S CB2D-14-S2F-S CB2D-14-TCH-S CC2D-04-DXE-S CC2D-04-DXE4-S CC2D-04-R3M-S CC2D-04-S2F-S CC2D-04-TCH-S CN2D-04-DXE-S CN2D-04-DXE4-S CN2D-04-R3M-S CN2D-04-S2F-S CN2D-04-TCH-S D462-002 D462-003-TC D462-004-TC D463-002 D463-002-TC D463-005 D466-000 D466-015-TC D466-020-TC D467-005-TC D467-010-TC D7506 D7506NC DHC-018/100/10 DHC-018/100/10-SC DHC-018/150/10 DHC-018/150/10-SC DHC-020/100/10-BC DHC-020/100/10-SC DHC-020/100/5 DHC-020/100/5-BC DHC-020/150/10 DHC-020/150/10-BC DHC-020/150/10-SC DHC-020/150/5 DHC-022/100/10 DHC-022/100/10-SC DHC-022/100/5 DHC-022/54/4 DHC-022/60/5 DRC-022/100 DRC-022/150 DRC-022/60 DTR-018/100/10 DTR-018/100/5 DTR-018/150/10 DTR-018/150/5 DTR-018/54/10 DTR-018/54/5 DXE-022/100/5 DXE-022/150/5 DXE-023/100/5 DXE-023/150/5 DXE-023/60/5 H4-H4-S H4-R2M-S H4-R3M-S H4-S2F-S MLA-4 URF-3AP