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Wire Guide Locking Device
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref AG-5591-01510(k) K202237
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Endoscopic guidewire holder FDA UDI
- Device Name
- Wire Guide Locking Device EUDAMED
- Model / Reference
- AG-5591-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959664913499 EUDAMEDFDA UDI
- Basic UDI-DI
- 695966495591000019E EUDAMED
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
- GMDN Term
- Endoscopic guidewire holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Wire Guide Locking Device by Hangzhou AGS MedTech Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K202237 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 695966495591000019E | Class I | 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 (3)
- EUDAMED 7dd88454-89da-4392-8335-3968dfa08ee2 85 fields · synced Jun 18, 2026
- FDA UDI a02edddb-8855-4b46-ae77-67e32289f57f 32 fields · synced May 30, 2026
- FDA 510(k) K202237 1 fields · synced May 18, 2026