Disposable Grasping Forceps
by Hangzhou AGS MedTech Co., Ltd. China EUDAMEDGUDID
Ref AG-5033-2323Model 5031 series~5036series、50310 series
Product code PKLEMDN G03080102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number6959664950310000139 | Date19 Jul 2022 | StatusActive |
| United States | GUDID listing GUDID | Number06959664903339 | Date23 Apr 2019 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Na
- Generic Name
- Gastrointestinal endoscopic clip, short-term
- Device Name
- Disposable Grasping Forceps
- Model / Reference
- 5031 series~5036series、50310 series, AG-5033-2323
- Primary DI / UDI-DI
- 06959664903339
- Basic UDI-DI
- 6959664950310000139
- 510(k) Number
- FDA Product Code
- PKL
- EMDN Code
- G03080102 Gastrointestinal endoscopy, extraction forceps, single-use
- GMDN Term
- Gastrointestinal endoscopic clip, short-term
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 876.4400
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000011718
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 3918c3ea-499d-4f7c-9490-b15769018dfa
- FDA UDI 577321b7-af4a-4afe-9f25-eaa9dfbd7e8c