Alternating Pressure Mattress
by Guangdong Yuehua Medical Instrument Factory Co., Ltd. 58 variants
Ref GIMA 28565, P4000IIE(B)
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 | Number694474959002N9 06944749540059 | Date16 Jul 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- Withdrawn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
- Alternation Pressure Mattresses
- Model / Reference
- GIMA 28565, P4000IIE(B)
- Primary DI / UDI-DI
- 06944749540059
- Basic UDI-DI
- 694474959002N9, 694474950030LF
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000004539
- Authorised representative
- Eunitor GmbH DE-AR-000005081
Other devices from Guangdong Yuehua Medical Instrument Factory Co., Ltd.
See all devices from Guangdong Yuehua Medical Instrument Factory 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