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Balloon dilatation catheter
EUDAMEDClass IIa (EU MDR)
Ref 090080050HCModel 040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HC
by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.
Identity
- Device Name
- Balloon dilatation catheter EUDAMED
- Model / Reference
- 040/045/050/055/060/065/070/080/090/100/120-020/040/060/080/100-050/075/090/120-H/HC EUDAMED090080050HC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971741707371 EUDAMED
- Basic UDI-DI
- 697174170BDC000188 EUDAMED
- Direct Marketing DI
- 06971741707371 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Balloon dilatation catheter by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 697174170BDC000188 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000037464
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e2634311-10cf-478b-8818-00b32f46cfe4 61 fields · synced Jun 18, 2026