Identity
- Device Name
- ESWL-Systeme EUDAMED
- Model / Reference
- 10000201512 EUDAMED3000PLUS-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04055207070468 EUDAMED
- Basic UDI-DI
- 405520723032020-00322278L EUDAMED
- EMDN Code
- Z12160101 EXTRACORPOREAL LITHOTRIPTERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The products are used to fragment concretions or to stimulate tissue by means of high-energy sound waves using the imaging locating methods of X-ray and ultrasound, as well as for motor-controlled patient positioning. Any use on the central circulatory system or nervous system is excluded. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
ESWL-Systeme by Richard Wolf GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 405520723032020-00322278L | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-PR-000033848
Sources (1)
- EUDAMED 0ae6f54b-89ce-4837-9148-58cb5f4d4307 61 fields · synced Jun 19, 2026