SEQUOIA Anti-decubitus Air pump & Air mattress system
by SEQUOIA-TWN Healthcare CO., Ltd. 25 variants
Ref GYM08-1-M7790-728O20-T-1, AUST03-68D-2W, Airflo, AUST03-SQNPSC04F, AUST03-NE7E-3W, GYM08-5010T-HD7-3W-UK, GYM08-ACCORA-9700N, GYM08-9700N, GYM08-AW-SQNTSC02F, GYM08-ED7A-2W-UK-SV, GYM08-2-ACCORA-728O20-T, GYM08-68D-2W-UK-SV, GYM08-1-9700N, GYM08-AW2010-EC7A-2W-VIKP.6, GYM08-2-ACCORA-728K20-T, GYM08-422O20B-L, GYM08-623O20-V-T, GYM08-AW2010-EC7A-2W-VIKP.7, GYM08-AW2010-EC7A-2W-VIKP5.2, GYM08-ACCORA-AX7-3W, GYM08-M7712-728H20-T, GYM08-AW-422O20B-LWF
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471987903MPAS7 | Date23 Jun 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SEQUOIA Anti-decubitus Air pump & Air mattress system
- Model / Reference
- GYM08-1-M7790-728O20-T-1, AUST03-68D-2W, Airflo, AUST03-SQNPSC04F, AUST03-NE7E-3W, GYM08-5010T-HD7-3W-UK, GYM08-ACCORA-9700N, GYM08-9700N, GYM08-AW-SQNTSC02F, GYM08-ED7A-2W-UK-SV, GYM08-2-ACCORA-728O20-T, GYM08-68D-2W-UK-SV, GYM08-1-9700N, GYM08-AW2010-EC7A-2W-VIKP.6, GYM08-2-ACCORA-728K20-T, GYM08-422O20B-L, GYM08-623O20-V-T, GYM08-AW2010-EC7A-2W-VIKP.7, GYM08-AW2010-EC7A-2W-VIKP5.2, GYM08-ACCORA-AX7-3W, GYM08-M7712-728H20-T, GYM08-AW-422O20B-LWF
- Primary DI / UDI-DI
- 04719879030174, 04719879030327, 04719879031201, 04719879030563, 04719879030099, 04719879030082, 04719879030167, 04719879030198, 04719879030303, 04719879030235, 04719879030266, 04719879030242, 04719879030150, 04719879030136, 04719879030549, 04719879030389, 04719879030297, 04719879030181, 04719879030280, 04719879030129, 04719879030334, 04719879030358
- Basic UDI-DI
- 471987903MPAS7
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class I
- EU market of registration
- GermanyDenmark
Manufacturer details
- EUDAMED SRN
- TW-MF-000004174
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from SEQUOIA-TWN Healthcare CO., Ltd.
Properties
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