Identity
- Trade Name
- QUBIX-Polyethylene and PowerFiber EUDAMED
- Device Name
- Ultra-High Molecular Weight Polyethylene Suture EUDAMED
- Model / Reference
- QN-7004- PEN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906122173412 EUDAMED
- Basic UDI-DI
- 890612217PEW7 EUDAMED
- EMDN Code
- H0102010299 SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER 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
Category: Polyester suture, non-bioabsorbable, multifilament
QUBIX-Polyethylene and PowerFiber by Qubix Medicare Private Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Polyester suture, non-bioabsorbable, multifilament.
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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 | 890612217PEW7 | 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 6e55e3ba-b512-43e1-bcdb-6a59d72f3627 61 fields · synced Jun 20, 2026