Identity
- Trade Name
- ThorCrack EUDAMED
- Device Name
- Peripheral IVL Balloon Dilatation Catheter EUDAMED
- Model / Reference
- LPAW6060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941785256296 EUDAMED
- Basic UDI-DI
- 69367337LP0043MQ EUDAMED
- EMDN Code
- C010402020199 PTA DILATATION CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
ThorCrack 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 | 69367337LP0043MQ | 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 23141d8f-d8bf-4be8-95dd-abec2dc7021c 61 fields · synced Jul 21, 2026