Cold AcuSnare
by Yangzhou Fartley Medical Instrument Technology Co., Ltd. China EUDAMEDGUDID
Ref CACS-10-030
Product code FGXEMDN G03030199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69709008510107Q | Date21 Jan 2025 | StatusActive |
| United States | GUDID listing GUDID | Number06936603226971 | Date21 Jan 2025 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Cold AcuSnare EUDAMEDDisposable Polypectomy Cold Snare GUDID
- Generic Name
- Mechanical-cutting endoscopic polypectomy snare
- Model / Ref / Catalog
- CACS-10-030, FTL-PSC-24-230-30-10-R
- Primary DI / UDI-DI
- 06936603226971
- Basic UDI-DI
- 69709008510107Q
- Direct Marketing DI
- 06936603226971
- FDA Product Code
- FGX
- EMDN Code
- G03030199 Polypectomy snares - other
- GMDN Term
- Mechanical-cutting endoscopic polypectomy snare
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 876.4730
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | CACS-10-030 | FTL-PSC-24-230-30-10-R |
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- CN-MF-000009371
- Authorised representative
- Prolinx GmbH DE-AR-000005129
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Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- 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
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED f693e380-7d05-41fb-b095-5d48a1f6c266
- FDA UDI e97b3431-41f4-48e6-9d23-5bc91cd9fe51