Identity
- Trade Name
- QUBIX-PDX EUDAMED
- Device Name
- Monofilament Polydioxanone Suture EUDAMED
- Model / Reference
- QN 9237RC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906122170749 EUDAMED
- Basic UDI-DI
- 890612217PDW5 EUDAMED
- EMDN Code
- H010101010101 POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Qubix-Pdx by Qubix Medicare Private Limited — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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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 | 890612217PDW5 | Class III | 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 9566a920-f2d9-4f26-a5ad-ba57e2fbff77 61 fields · synced Jun 18, 2026