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Multi-Stage Balloon Dilatation Catheter
EUDAMEDClass IIa (EU MDR)
Ref AF-D0509TBC06/07/0830Model Multi-Stage Balloon Dilatation Catheter
Identity
- Trade Name
- Multi-Stage Balloon Dilatation Catheter EUDAMED
- Device Name
- Multi-Stage Balloon Dilatation Catheter EUDAMED
- Model / Reference
- Multi-Stage Balloon Dilatation Catheter EUDAMEDAF-D0509TBC06/07/0830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127891076 EUDAMED
- Basic UDI-DI
- 697067138MS055J4 EUDAMED
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Multi-Stage Balloon Dilatation Catheter by Alton (Shanghai) Medical Instruments Co., Ltd. — Class IIa — 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 | 697067138MS055J4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b76fa838-85df-4568-b468-7e8b7938bfc2 61 fields · synced Jun 19, 2026