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Sphincterotome
EUDAMEDClass IIb (EU MDR)
Ref AG-5098-0525-URef AG-5091-1525Ref AG-50917-0530-W3545Ref AG-50913-0525-W2545Ref AG-50910-0520-W3526Ref AG-50910-0530-W3545Ref AG-50912-0520-URef AG-50912-0525Ref AG-50913-0530-W2526Ref AG-50913-0520-W3526Ref AG-50910-0525-W3526Ref AG-5096-0525-URef AG-50913-0525-W3526Ref AG-50912-0530-URef AG-5093-0525Ref AG-5093-0530-URef AG-5098-0520Ref AG-5096-0525Ref AG-5093-1530-URef AG-5096-0530-URef AG-5098-1530-U Ref AG-5093-1520-U
Identity
- Device Name
- Sphincterotome EUDAMED
- Model / Reference
- AG-5098-0525-U EUDAMEDAG-5091-1525 EUDAMEDAG-50917-0530-W3545 EUDAMEDAG-50913-0525-W2545 EUDAMEDAG-50910-0520-W3526 EUDAMEDAG-50910-0530-W3545 EUDAMEDAG-50912-0520-U EUDAMEDAG-50912-0525 EUDAMEDAG-50913-0530-W2526 EUDAMEDAG-50913-0520-W3526 EUDAMEDAG-50910-0525-W3526 EUDAMEDAG-5096-0525-U EUDAMEDAG-50913-0525-W3526 EUDAMEDAG-50912-0530-U EUDAMEDAG-5093-0525 EUDAMEDAG-5093-0530-U EUDAMEDAG-5098-0520 EUDAMEDAG-5096-0525 EUDAMEDAG-5093-1530-U EUDAMEDAG-5096-0530-U EUDAMEDAG-5098-1530-U EUDAMEDAG-5093-1520-U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959664912089 EUDAMED06959664901595 EUDAMED06959664934401 EUDAMED06959664934340 EUDAMED06959664934036 EUDAMED06959664934128 EUDAMED06959664934289 EUDAMED06959664934296 EUDAMED06959664934364 EUDAMED06959664934333 EUDAMED06959664934074 EUDAMED06959664911983 EUDAMED06959664934357 EUDAMED06959664934326 EUDAMED06959664901687 EUDAMED06959664910566 EUDAMED06959664912041 EUDAMED06959664910764 EUDAMED06959664910597 EUDAMED06959664911990 EUDAMED06959664934265 EUDAMED06959664919118 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 (22)
- EUDAMED 9c950e04-fcad-4588-b85f-328d088f648e 61 fields · synced Oct 6, 2026
- EUDAMED f06e4385-ec45-4e25-8c0f-aeaf2ee74639 61 fields · synced May 11, 2026
- EUDAMED 93c5ef73-6e37-4016-99fe-64edee7978be 61 fields · synced May 16, 2026
- EUDAMED a9f152b2-c7fd-437f-bc46-ac556864b1fa 61 fields · synced May 16, 2026
- EUDAMED fccd70fe-c964-479b-b412-1717793eabcf 61 fields · synced May 16, 2026
- EUDAMED e5bc5d91-0a35-40e7-a497-6c9d75cf888c 61 fields · synced May 16, 2026
- EUDAMED b2df11c4-18f9-4427-81bc-441d569148cd 61 fields · synced May 16, 2026
- EUDAMED 0059cc50-9fa3-4ba0-bd5b-d883a3212dcd 61 fields · synced May 17, 2026
- EUDAMED 700c0678-bb3d-4b19-ab61-e26b0803eac5 61 fields · synced May 17, 2026
- EUDAMED ec83bf9b-257c-4175-9135-26c009e64d60 61 fields · synced May 17, 2026
- EUDAMED 7e96ef1e-4368-4e84-8f8f-fc90f066101d 61 fields · synced May 17, 2026
- EUDAMED e7b15884-79ab-4968-a5dc-48fe1fec5e11 61 fields · synced May 17, 2026
- EUDAMED 9fbd4b02-c34c-4b6a-a2ab-7e5fa4c41c9c 61 fields · synced May 17, 2026
- EUDAMED 93013b86-6052-46cc-848e-1267aadae132 61 fields · synced May 17, 2026
- EUDAMED 63532e03-6631-4c76-ac25-63d42b209212 61 fields · synced May 18, 2026
- EUDAMED 4b61d64e-d237-46fa-a4ff-6590557bff03 61 fields · synced May 18, 2026
- EUDAMED 21fd7925-bbb6-4e32-a468-8bb82de1d730 61 fields · synced May 18, 2026
- EUDAMED e5395777-6617-4dd4-b7fd-3ab5b0f8c04d 61 fields · synced May 18, 2026
- EUDAMED 79fbda82-b4fd-4b35-a3a3-caf962bc14c9 61 fields · synced May 18, 2026
- EUDAMED 890bf7bc-3937-4559-b4cf-8d438d6ef726 61 fields · synced May 18, 2026
- EUDAMED 09a8d704-0c0d-41c5-b5e0-9d5784b3ea99 61 fields · synced May 18, 2026
- EUDAMED 1304516b-7ed0-40ba-8f6f-1b29bc24494c 61 fields · synced May 19, 2026