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SUTUREMAXX™ PET SUTURE WHITE USP 3 - EUDAMED Registration D-8681596022366BL

Access comprehensive regulatory information for SUTUREMAXX™ PET SUTURE WHITE USP 3 in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI D-8681596022366BL and manufactured by Tulpar Tıbbi Ürünler İthalat İhracat Sanayi ve Ticaret L.T.D Ş.T.İ in Türkiye.

This page provides complete registration details including trade name (SUTUREMAXX™ PET SUTURE WHITE USP 3), manufacturer information, competent authority (Turkish Medicine and Medical Devices Agency), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class IIb
D-8681596022366BL
No
SUTUREMAXX™ PET SUTURE WHITE USP 3
Trade Name: SUTUREMAXX™ PET SUTURE WHITE USP 3
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Device Description (EMDN)

ANCHORS, TENDON AND LIGAMENT SYNTHESIS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120102
Trade Name
SUTUREMAXX™ PET SUTURE WHITE USP 3
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-8681596022366BL
Basic UDI
B-8681596022366BL
Version Date
February 18, 2025
Manufacturer Last Update
November 02, 2023
Active Status
No
Manufacturer
Country
Türkiye
Country Type
EU_EXTENDED
Address
177 Macun Mahallesi Ankara
Email
info@tulparmed.com
Regulatory Information
Competent Authority
Turkish Medicine and Medical Devices Agency
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Türkiye
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No