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Stone Retrieval Balloon
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AG-5052-1785Ref AG-5453-18Ref AG-5053-20-85-12-15Ref AG-5051-2018Ref AG-5052-1712Ref AG-5051-2317-18Ref AG-5053-2085Ref AG-5053-2317-13-15-18Ref AG-5052-2317-12Ref AG-5052-2317-13-15-18Ref AG-5453-15Ref AG-5053-2317-18Ref AG-5051-2015Ref AG-5052-1718Ref AG-5053-2018Ref AG-5052-20-85-12-15Ref AG-5052-2317-85-12-15Ref AG-5051-2317-12Ref AG-5051-2317-85Ref AG-5052-2015Ref AG-5052-2317-85Ref AG-5051-2317-13-15-18Ref AG-5451-18Ref AG-5052-2018Ref AG-5451-15Ref AG-5052-17-13-15-18Ref AG-5451-12Ref AG-5051-20-85-12-15Ref AG-5051-2012Ref AG-5453-15-18-20Ref AG-5052-2012Ref AG-5053-20-13-15-18Ref AG-5052-1715
Identity
- Device Name
- Stone Retrieval Balloon EUDAMED
- Model / Reference
- AG-5052-1785 EUDAMEDAG-5453-18 EUDAMEDAG-5053-20-85-12-15 EUDAMEDAG-5051-2018 EUDAMEDAG-5052-1712 EUDAMEDAG-5051-2317-18 EUDAMEDAG-5053-2085 EUDAMEDAG-5053-2317-13-15-18 EUDAMEDAG-5052-2317-12 EUDAMEDAG-5052-2317-13-15-18 EUDAMEDAG-5453-15 EUDAMEDAG-5053-2317-18 EUDAMEDAG-5051-2015 EUDAMEDAG-5052-1718 EUDAMEDAG-5053-2018 EUDAMEDAG-5052-20-85-12-15 EUDAMEDAG-5052-2317-85-12-15 EUDAMEDAG-5051-2317-12 EUDAMEDAG-5051-2317-85 EUDAMEDAG-5052-2015 EUDAMEDAG-5052-2317-85 EUDAMEDAG-5051-2317-13-15-18 EUDAMEDAG-5451-18 EUDAMEDAG-5052-2018 EUDAMEDAG-5451-15 EUDAMEDAG-5052-17-13-15-18 EUDAMEDAG-5451-12 EUDAMEDAG-5051-20-85-12-15 EUDAMEDAG-5051-2012 EUDAMEDAG-5453-15-18-20 EUDAMEDAG-5052-2012 EUDAMEDAG-5053-20-13-15-18 EUDAMEDAG-5052-1715 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959664907467 EUDAMED06959664910733 EUDAMED06959664907573 EUDAMED06959664907313 EUDAMED06959664907474 EUDAMED06959664900208 EUDAMED06959664907535 EUDAMED06959664902578 EUDAMED06959664907351 EUDAMED06959664907399 EUDAMED06959664910726 EUDAMED06959664903254 EUDAMED06959664907306 EUDAMED06959664907498 EUDAMED06959664907566 EUDAMED06959664907443 EUDAMED06959664907382 EUDAMED06959664901137 EUDAMED06959664902660 EUDAMED06959664907429 EUDAMED06959664907344 EUDAMED06959664900093 EUDAMED06959664910696 EUDAMED06959664907436 EUDAMED06959664910689 EUDAMED06959664907511 EUDAMED06959664911013 EUDAMED06959664907320 EUDAMED06959664907290 EUDAMED06959664911150 EUDAMED06959664907412 EUDAMED06959664907580 EUDAMED06959664907481 EUDAMED
- Basic UDI-DI
- 695966495051000014B EUDAMED
- EMDN Code
- G0301010401 BILIARY 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
EUDAMEDEUDAMED
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
Stone Retrieval Balloon 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 | K200173 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 695966495051000014B | 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 (34)
- EUDAMED 79908052-6a50-4a17-860f-af1408b51ecc 61 fields · synced Oct 5, 2026
- EUDAMED ba880fcc-c64b-4b14-aea5-3144a15b51df 61 fields · synced May 11, 2026
- EUDAMED 00764225-19ef-482b-8584-5e9c39abe805 61 fields · synced May 11, 2026
- EUDAMED 31659bef-b49b-42a5-a57f-b1b3f32ed49a 61 fields · synced May 16, 2026
- EUDAMED ba438512-15a3-43c3-9b54-ad2ece246063 61 fields · synced May 17, 2026
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- EUDAMED dba37d7b-c411-49c8-a728-7d4ad50827d4 61 fields · synced May 17, 2026
- EUDAMED 66da0aa1-cfc6-480a-b9a5-b0caeb883f7c 61 fields · synced May 17, 2026
- EUDAMED 0e6b5055-9751-492f-a42d-50bdfe426cb9 61 fields · synced May 17, 2026
- EUDAMED 7b3c1739-65ae-4e1f-a14d-28bd2118aa1d 61 fields · synced May 17, 2026
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- EUDAMED 59d4f707-9638-425e-a975-eeea9551bea4 61 fields · synced May 17, 2026
- EUDAMED 4741fab7-ff37-491b-821f-75928d3ce0cd 61 fields · synced May 18, 2026
- EUDAMED be6f875e-560e-4b3e-9725-529afe4c26cd 61 fields · synced May 18, 2026
- EUDAMED 337a3725-ec20-41d7-bd0d-ce641616163d 61 fields · synced May 18, 2026
- EUDAMED 5382af86-be9f-4147-a5e0-7e891ca94fe0 61 fields · synced May 18, 2026
- EUDAMED c6c37dfc-01d7-4bb0-bbb4-f9a8069911e8 61 fields · synced May 18, 2026
- EUDAMED fa34a4e8-8a51-49ba-b667-498379888239 61 fields · synced May 18, 2026
- EUDAMED dc7d8f84-d503-4742-8f08-2c9585ee87f7 61 fields · synced May 18, 2026
- EUDAMED c7c0bd69-d218-4cce-a540-f3901c3f2058 61 fields · synced May 18, 2026
- EUDAMED 24bdec16-c16a-462b-87a4-e38f84ac8ecf 61 fields · synced May 18, 2026
- EUDAMED 84c27053-7f28-4020-add3-e35378265d8d 61 fields · synced May 18, 2026
- EUDAMED ab889e75-a37f-4f0e-a429-dfdebd9e3883 61 fields · synced May 18, 2026
- EUDAMED e68e8ee6-6cd3-4ed8-a90e-83cca76bb263 61 fields · synced May 19, 2026
- EUDAMED f37ae6c5-db7b-41ec-9507-5efafdfb09ad 61 fields · synced May 19, 2026
- EUDAMED 8d9ed525-4fd2-4157-89b7-c9b1280e359e 61 fields · synced May 19, 2026
- EUDAMED 2685d067-7faa-4d60-9d49-c704ea659234 61 fields · synced May 19, 2026
- EUDAMED 9d859bc7-c3f0-4860-8dc0-2271d13590c8 61 fields · synced May 19, 2026
- FDA 510(k) K200173 1 fields · synced May 18, 2026