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Balloon Dilatation Catheter
EUDAMEDClass IIa (EU MDR)
Ref 090020120Model 040/045/050/055/060/065 /070/080/090/100/120-020/040/060/080/100-050/075/090/120
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 EUDAMED090020120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971741703304 EUDAMED
- Basic UDI-DI
- 697174170BDC00028A EUDAMED
- Direct Marketing DI
- 06971741703304 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
Category: Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED
Similar devices
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 | 697174170BDC00028A | 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 423b8924-c22e-45c4-b4e0-e8a0c6857992 61 fields · synced Jun 17, 2026