Identity
- Trade Name
- PTA Balloon Catheter (PVQ) EUDAMED
- Model / Reference
- 15PVQ040020APO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649094802 EUDAMED
- Basic UDI-DI
- B-04051649094802 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
Category: Peripheral angioplasty balloon catheter, basic
PTA Balloon Catheter (PVQ) by QualiMed Innovative Medizinprodukte GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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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-04051649094802 | Class IIa | Active |
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Manufacturer
- Manufacturer
- QualiMed Innovative Medizinprodukte GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (1)
- EUDAMED 041ac3ed-4a7e-4d74-b564-8c63b53b2f3a 61 fields · synced Jun 18, 2026