Disposable bed cover
by Cleancare Co., Ltd 3 variants
Ref 006, 004, 005, 002, 009, 010, 008, 007Model 001，002，003，004，005，006，007，008，009，010
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 | Number697810648bedcover96 | Date30 May 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- Withdrawn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
- Disposable bed cover
- Model / Reference
- 001，002，003，004，005，006，007，008，009，010, 006, 004, 005, 002, 009, 010, 008, 007
- Primary DI / UDI-DI
- 06978106480351, 06978106480337, 06978106480344, 06978106480313, 06978106480382, 06978106480399, 06978106480375, 06978106480368
- Basic UDI-DI
- 697810648bedcover96
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042673
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Cleancare 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