Identity
- Trade Name
- UBIX-Silk EUDAMED
- Device Name
- Black Braided Silk Suture EUDAMED
- Model / Reference
- QN 5080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906122171562 EUDAMED
- Basic UDI-DI
- 890612217BSVR EUDAMED
- EMDN Code
- H010202020301 SILK WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
UBIX-Silk by Qubix Medicare Private Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890612217BSVR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Qubix Medicare Private Limited
- EUDAMED SRN
- IN-MF-000042759
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (1)
- EUDAMED dc96aea7-024f-46ce-b113-ea7da4712172 61 fields · synced Jul 13, 2026