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Disposable Stone Extraction Basket
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AG-5063-S2524G
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Biliary/urinary stone retrieval basket, single-use FDA UDI
- Device Name
- Disposable Stone Extraction Basket EUDAMED
- Model / Reference
- AG-5063-S2524G EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959664900833 EUDAMEDFDA UDI
- Basic UDI-DI
- 6959664950620000159 EUDAMED
- 510(k) Number
- K201509 FDA UDI
- FDA Product Code
- LQR FDA UDI
- EMDN Code
- G0305010202 DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, NON-REVOLVING EUDAMED
- GMDN Term
- Biliary/urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Stone Extraction Basket by Hangzhou AGS MedTech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6959664950620000159 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 f4eaaf00-e6ad-4015-9018-49067b450095 61 fields · synced Oct 6, 2026
- FDA UDI 390ba6b8-16df-46cd-9fc0-8c5a035fbc6e 33 fields · synced May 29, 2026