Identity
- Device Name
- Balloon Dilatation Catheter EUDAMED
- Model / Reference
- BDC842863 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251790228631 EUDAMED
- Basic UDI-DI
- B-04251790228631 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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
Balloon Dilatation Catheter by SWL Medizin 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-04251790228631 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SWL Medizin GmbH
- EUDAMED SRN
- DE-MF-000008000
Sources (1)
- EUDAMED 42b31105-8020-4581-b203-19ca28618618 61 fields · synced Jun 18, 2026