Identity
- Trade Name
- PTCA Balloon Catheter (PC) EUDAMED
- Model / Reference
- PC4516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649010697 EUDAMED
- Basic UDI-DI
- B-04051649010697 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 QualiMed Innovative Medizinprodukte 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-04051649010697 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- QualiMed Innovative Medizinprodukte GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (1)
- EUDAMED 57d3f8c6-ed1e-4215-b517-730f9f833d34 61 fields · synced Jun 18, 2026