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Disposable Sclerotherapy Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AG-5311-2416-2204M
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Disposable Sclerotherapy Needle EUDAMEDthe Catheter OD is 2.4mm, working length is 1600mm, model of needle is 22, needle extension length is 4 mm, the headend type is metal cap FDA UDI
- Model / Reference
- AG-5311-2416-2204M EUDAMEDFDA UDI
- Description
- the Catheter OD is 2.4mm, working length is 1600mm, model of needle is 22, needle extension length is 4 mm, the headend type is metal cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959664932124 EUDAMEDFDA UDI
- Basic UDI-DI
- 695966495311000013Y EUDAMED
- 510(k) Number
- K190032 FDA UDI
- FDA Product Code
- FBK FDA UDI
- EMDN Code
- G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
Disposable Sclerotherapy Needle 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 | 695966495311000013Y | 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 b65b47ac-6722-4473-88d2-04c931a99ecd 61 fields · synced Jul 11, 2026
- FDA UDI 3a1cd587-7007-469e-9dc4-13b960b0011f 34 fields · synced May 30, 2026