Identity
- Trade Name
- QUBIX-Nylon EUDAMED
- Device Name
- Monofilament Polyamide Suture EUDAMED
- Model / Reference
- QN 3317 EUDAMEDQN 3326N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906122171579 EUDAMED08906122172057 EUDAMED
- Basic UDI-DI
- 890612217NYX9 EUDAMED
- EMDN Code
- H010201010101 POLYAMIDE MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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
QUBIX-Nylon 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 | 890612217NYX9 | 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 (2)
- EUDAMED 45d6f924-f7f4-47c8-8b54-50b430ee519d 61 fields · synced Jul 23, 2026
- EUDAMED 552b872f-a57d-4cbe-9656-7747c7a2875f 61 fields · synced May 18, 2026