Identity
- Device Name
- PEEK Suture Anchor EUDAMED
- Model / Reference
- SAPC01 EUDAMED91-7903-003-65 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970763897459 EUDAMED
- Basic UDI-DI
- B-06970763897459 EUDAMED
- EMDN Code
- P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Category: Hand-held surgical retractor, reusable
PEEK Suture Anchor by Beijing Delta Medical Science & Technology Corp. Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand-held surgical retractor, reusable.
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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-06970763897459 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018139
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED e103c3a5-cc53-454c-b89c-aeab7c389b10 61 fields · synced Jul 8, 2026