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ESWL-Systeme
EUDAMEDClass IIb (EU MDR)
Ref 3000-004Model 10000201512Ref 3000PLUS-004Ref 3000PLUS-003
Identity
- Device Name
- ESWL-Systeme EUDAMED
- Model / Reference
- 10000201512 EUDAMED3000-004 EUDAMED3000PLUS-004 EUDAMED3000PLUS-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04055207072332 EUDAMED04055207069424 EUDAMED04055207069417 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 |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-PR-000033848
Sources (3)
- EUDAMED 9ce55a91-d385-4c7e-9604-1b810e79df56 61 fields · synced Jul 20, 2026
- EUDAMED 3ca22ef9-264e-4fcb-92db-1d5b2c044493 61 fields · synced May 16, 2026
- EUDAMED b29c2cd7-d105-46e9-a466-abaa598d4619 61 fields · synced May 18, 2026