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Non absorbable Surgical Polypropylene Suture[EN]
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref IFUModel 6-0 1/2 Round Bodied 16mm 75cm
Identity
- Trade Name
- Non absorbable Surgical Polypropylene Suture[EN] EUDAMED
- Device Name
- Non absorbable Surgical Polypropylene Suture EUDAMED
- Model / Reference
- 6-0 1/2 Round Bodied 16mm 75cm EUDAMEDIFU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971642803486 EUDAMED
- Basic UDI-DI
- B-06971642803486 EUDAMED
- EMDN Code
- H010201010401,H010201010402,H010201010403 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 Polypropylene Suture[EN] 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 | K230746 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06971642803486 | 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 3436f207-a805-4680-a4b6-69c53109318a 61 fields · synced Jul 8, 2026
- FDA 510(k) K230746 1 fields · synced May 18, 2026