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Non absorbable Surgical Polyester Braided Suture
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref IFUModel 6-0 3/8 Reverse Cutting 16mm 75cm
Identity
- Trade Name
- Non absorbable Surgical Polyester Braided Suture EUDAMED
- Device Name
- Non absorbable Surgical Polyester Braided Suture EUDAMED
- Model / Reference
- 6-0 3/8 Reverse Cutting 16mm 75cm EUDAMEDIFU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971642803578 EUDAMED
- Basic UDI-DI
- B-06971642803578 EUDAMED
- EMDN Code
- H010201020201,H010201020202,H010201020203 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 Polyester Braided 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 | K231183 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06971642803578 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Haidike Medical Products Co Ltd
- EUDAMED SRN
- CN-MF-000026113
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 35654562-bc70-4f6b-ab35-ea3921248e4f 61 fields · synced Oct 6, 2026
- FDA 510(k) K231183 1 fields · synced May 18, 2026