Identity
- Trade Name
- Balloon Inflation Devices EUDAMED
- Device Name
- Balloon Inflation Devices EUDAMED
- Model / Reference
- 860101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970353513707 EUDAMED
- Basic UDI-DI
- 69703535100000000000001T8 EUDAMED
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Balloon Inflation Devices by Jingzhou Yihai Technology Ltd. — Class I — 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 | 69703535100000000000001T8 | Class I | Active |
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Manufacturer
- Manufacturer
- Jingzhou Yihai Technology Ltd.
- EUDAMED SRN
- CN-MF-000025055
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 8f2291ba-5c44-4aba-932a-f7d2acecfd62 61 fields · synced Jun 19, 2026