Identity
- Trade Name
- PTA Balloon Catheter (PVQ) EUDAMED
- Model / Reference
- 12PVQ030280CPO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649235014 EUDAMED
- Basic UDI-DI
- B-04051649235014 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa 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
PTA Balloon Catheter (PVQ) by Q3 Medical Germany GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04051649235014 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Q3 Medical Germany GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (1)
- EUDAMED 113d9eb0-3914-4af4-a214-8224778ce1c4 61 fields · synced Jul 8, 2026