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Balloon Dilatation Catheter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AG-5251-185519
Identity
- Device Name
- Balloon Dilatation Catheter EUDAMED
- Model / Reference
- AG-5251-185519 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959664927069 EUDAMED
- Basic UDI-DI
- 695966495251000015H EUDAMED
- EMDN Code
- G0301010101 OESOPHAGEAL BALLOON CATHETERS, LOW PRESSURE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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 Dilatation Catheter by Hangzhou AGS MedTech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213578 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 695966495251000015H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou AGS MedTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011718
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 61d600d2-75c7-4e78-a7dc-9288fd31480d 61 fields · synced Jun 19, 2026
- FDA 510(k) K213578 1 fields · synced May 18, 2026