Identity
- Trade Name
- ShockFast EUDAMED
- Device Name
- Peripheral Intravascular Lithotripsy Catheter EUDAMED
- Model / Reference
- 629957 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956014499573 EUDAMED
- Basic UDI-DI
- 69560144PILCUK EUDAMED
- Direct Marketing DI
- 06956014499573 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Category: Peripheral angioplasty balloon catheter, basic
ShockFast by Shunmei Medical Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Peripheral angioplasty balloon catheter, basic.
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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 | 69560144PILCUK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shunmei Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e2a8fed4-392a-4ecf-8f3a-7987203b2255 61 fields · synced Jun 18, 2026