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Non-absorbable Surgical Suture With / Without Needle - Nylon Suture
EUDAMEDClass IIb (EU MDR)
Ref NL81040B4Model With Needle;Without NeedleRef S6785Ref S5886
Identity
- Device Name
- Non-absorbable Surgical Suture With / Without Needle - Nylon Suture EUDAMED
- Model / Reference
- With Needle;Without Needle EUDAMEDNL81040B4 EUDAMEDS6785 EUDAMEDS5886 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938535583313 EUDAMED06938535529601 EUDAMED06938535529786 EUDAMED
- Basic UDI-DI
- 69385355NLHW EUDAMED
- Direct Marketing DI
- 06938535583313 EUDAMED06938535529601 EUDAMED06938535529786 EUDAMED
- EMDN Code
- H010201010101 POLYAMIDE MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDDenmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Non-absorbable Surgical Suture With / Without Needle - Nylon Suture by Huaiyin Medical Instruments Co., Ltd. — Class IIb — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69385355NLHW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Huaiyin Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000003351
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (3)
- EUDAMED ec2e4c00-8dcc-46d6-8161-f0e20e80d8da 61 fields · synced Jul 19, 2026
- EUDAMED 72d75610-3f48-46a9-bc42-9c5ebfb68d03 61 fields · synced Jul 15, 2026
- EUDAMED bb1ce8d4-3645-415e-8488-f450bf7e843f 61 fields · synced Jul 19, 2026