Identity
- Device Name
- Intravascular Lithotripsy Generator EUDAMED
- Model / Reference
- LP-AW-200A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941785256159 EUDAMED
- Basic UDI-DI
- 69367337LP0044MS EUDAMED
- Direct Marketing DI
- 06941785256159 EUDAMED
- EMDN Code
- C01040199,C0104020299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intravascular Lithotripsy Generator by Lepu Medical Technology (Beijing) Co., Ltd. — 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 | 69367337LP0044MS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lepu Medical Technology (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001408
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED c8e41a83-d15c-48cb-99fc-138cc64a9f5c 61 fields · synced Jul 26, 2026