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Non absorbable Surgical Silk Suture
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref IFUModel 2# 3/8 Reverse Cutting 40mm 75cm510(k) K232355
Identity
- Trade Name
- Non absorbable Surgical Silk Suture EUDAMED
- Device Name
- Non absorbable Surgical Silk Suture EUDAMED
- Model / Reference
- 2# 3/8 Reverse Cutting 40mm 75cm EUDAMEDIFU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971642803011 EUDAMED
- Basic UDI-DI
- B-06971642803011 EUDAMED
- EMDN Code
- H010202020301,H010202020302 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Non absorbable Surgical Silk Suture by Shandong Haidike Medical Products Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232355 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06971642803011 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Haidike Medical Products Co Ltd
- EUDAMED SRN
- CN-MF-000026113
- FDA Applicant
- Shandong Haidike Medical Product Co., Ltd.
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 18b07c91-2b4f-4983-a024-940e37e38932 85 fields · synced Oct 6, 2026
- EUDAMED 63b89650-f645-43d6-b36e-dff558d6500b 61 fields · synced Jul 12, 2026
- FDA 510(k) K232355 1 fields · synced May 18, 2026