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Non-absorbable Surgical Suture With / Without Needle - Silk Braided Suture
EUDAMEDClass IIb (EU MDR)
Ref SK73018B0Model With Needle；Without Needle
Identity
- Device Name
- Non-absorbable Surgical Suture With / Without Needle - Silk Braided Suture EUDAMED
- Model / Reference
- With Needle；Without Needle EUDAMEDSK73018B0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16938535524634 EUDAMED
- Basic UDI-DI
- 69385355SKJB EUDAMED
- EMDN Code
- H010202020301 SILK WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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 - Silk Braided 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 | 69385355SKJB | 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 (1)
- EUDAMED 629a5815-a56d-45f5-9f12-9d2b5df547d2 61 fields · synced Jun 18, 2026