Bowa
by Conmed Corporation United States EUDAMEDGUDID
Ref 951-000
Product code FYDEMDN Z12019004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number084585408515DA | Date12 Nov 2025 | StatusActive |
| United States | GUDID listing GUDID | Number30845854081697 | Date30 Sep 2020 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Surgical plume evacuation system filter
- Device Name
- Non-orthopedic, Non-active, Smoke Evacuation Filter
- Model / Ref / Catalog
- 951-000
- Primary DI / UDI-DI
- 30845854081697
- Basic UDI-DI
- 084585408515DA
- 510(k) Number
- FDA Product Code
- FYD
- EMDN Code
- Z12019004 Surgical smoke evacuation systems
- GMDN Term
- Surgical plume evacuation system filter
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 878.5070
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- Sterile: No
- Single Use: No
- 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
- Expiration Date: No
Sources (2)
- EUDAMED 39765af8-c492-4ce1-8f19-1e016bbb5a68
- FDA UDI 72c4dbe3-e982-47d1-b873-5a3de8f42ed4