N61G05-GE005
by Leboo Healthcare Products Limited
Ref N61G05-GE005Model Nonwoven Bed Cover, PE Coated Bed Cover, Blanket Cover, Chair Cover, Nonwoven fabrics Small Products, PE Pallet Cover, CPE Mattress Cover, PVC Bed（mattress) Cover, PVC Pillow Case and other customized specifications
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 | Number697442484L10Q8 06974424845278 | Date8 Aug 2024 | 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- Withdrawn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
- Model / Reference
- Nonwoven Bed Cover, PE Coated Bed Cover, Blanket Cover, Chair Cover, Nonwoven fabrics Small Products, PE Pallet Cover, CPE Mattress Cover, PVC Bed（mattress) Cover, PVC Pillow Case and other customized specifications, N61G05-GE005
- Primary DI / UDI-DI
- 06974424845278
- Basic UDI-DI
- 697442484L10Q8
- EMDN Code
- T030502 Bed and stretcher hygienic covers
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000008521
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Leboo Healthcare Products Limited
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