Identity
- Trade Name
- UniCort™ EUDAMED
- Device Name
- Suture Buttons EUDAMED
- Model / Reference
- EB0F EUDAMEDF06004246BE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927098409062 EUDAMED
- Basic UDI-DI
- B-06927098409062 EUDAMED
- EMDN Code
- H900301 SUTURE BUTTONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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: Tendon/ligament bone anchor, non-bioabsorbable
UniCort™ by Star Sports Medicine 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-06927098409062 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Star Sports Medicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000027866
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 97828953-801c-4949-b1b3-365db31df343 61 fields · synced Jul 12, 2026