← Back to catalogue
Qubix-Pdx
EUDAMEDClass III (EU MDR)
Ref QN 9262Ref QN 9221Ref QN 9132Ref QN 9133Ref QN 9210Ref QN 9234Ref QN 9304
Identity
- Trade Name
- QUBIX-PDX EUDAMED
- Device Name
- Monofilament Polydioxanone Suture EUDAMED
- Model / Reference
- QN 9262 EUDAMEDQN 9221 EUDAMEDQN 9132 EUDAMEDQN 9133 EUDAMEDQN 9210 EUDAMEDQN 9234 EUDAMEDQN 9304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906122170800 EUDAMED08906122170794 EUDAMED08906122170756 EUDAMED08906122170763 EUDAMED08906122170824 EUDAMED08906122172507 EUDAMED08906122171234 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 EUDAMEDSlovakia 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
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
- Monoswift — RIVERPOINT MEDICAL LLC · Class II
- DemeDIOX — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- Maxon — Covidien LP · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qubix Medicare Private Limited
- EUDAMED SRN
- IN-MF-000042759
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (7)
- EUDAMED 2ac9e107-d305-4902-b4d7-7fccf8d2a3ab 61 fields · synced Sep 30, 2026
- EUDAMED 55309dd6-34bf-4ed7-926f-92a332334453 61 fields · synced May 16, 2026
- EUDAMED 67b27562-0015-42f6-9427-823c819a2b14 61 fields · synced May 17, 2026
- EUDAMED 0964e58f-343d-4d6a-81df-43812dd0a8ed 61 fields · synced May 17, 2026
- EUDAMED e06b2979-8252-44d4-8b0c-148611565e7d 61 fields · synced May 17, 2026
- EUDAMED 903a9541-ecdc-439a-8df1-3f23011c6e03 61 fields · synced May 17, 2026
- EUDAMED 241e461b-67ee-42e2-80d4-42f3697978a4 61 fields · synced May 18, 2026