Anti Decubitus Mattress
by Shenzhen Fitconn Technology Co., ltd China EUDAMED
Ref FU-AM003Model FU-AM001, FU-AM002, FU-AM003, FU-AM001L EMDN V080701
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI26/1008022 | Date1 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- FI26/1008022 Supplemented
Quality management system EU MDR
- Notified body
- SGS FIMKO OY 0598
- Issued
- 1 Jul 2026
- Expires
- 16 Apr 2031
- Reason
- Other
Specification
- Model / Reference
- FU-AM001, FU-AM002, FU-AM003, FU-AM001L
- Primary DI / UDI-DI
- 06970470480814
- Basic UDI-DI
- 697047048FUADMKH
- Direct Marketing DI
- 06970470480814
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000024538
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Shenzhen Fitconn Technology Co., ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: 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
Sources (1)
- EUDAMED b62e72b8-5225-4825-abcf-3bf83f5fb385