Identity
- Trade Name
- PTCA Balloon Catheter (PC) EUDAMED
- Model / Reference
- PC1512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649009875 EUDAMED
- Basic UDI-DI
- B-04051649009875 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PTCA Balloon Catheter (PC) by Q3 Medical Germany GmbH — Class III — 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-04051649009875 | Class III | Active |
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Manufacturer
- Manufacturer
- Q3 Medical Germany GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (1)
- EUDAMED 68970110-07f5-47fd-90b4-e66ce4e43977 61 fields · synced Sep 17, 2026