Identity
- Device Name
- Sphincterotome EUDAMED
- Model / Reference
- AG-5098-0530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959664912065 EUDAMED
- Basic UDI-DI
- 695966495091000016F EUDAMED
- EMDN Code
- G03040202 PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Sphincterotome by Hangzhou AGS MedTech Co., Ltd. — Class IIb — 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 | 695966495091000016F | Class IIb | 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 (1)
- EUDAMED e2614e74-41b3-4130-a683-09658dba6828 61 fields · synced Jun 18, 2026