Identity
- Device Name
- Suture Anchors EUDAMED
- Model / Reference
- FP165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958289301018 EUDAMED
- Basic UDI-DI
- B-06958289301018 EUDAMED
- EMDN Code
- P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Category: Hand-held surgical retractor, reusable
Suture Anchors by Shanghai Forerunner Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06958289301018 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai Forerunner Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027294
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f8b4fcb3-295c-48a9-ace3-5dce27213bed 61 fields · synced Jun 18, 2026