ProTect
by Blue Sail Medical Co., Ltd 7 variants
Ref Q1105EXModel EM0102
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 | Number69332655EM01021562864B 05206970070905 | Date15 Dec 2021 | 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- Withdrawn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 Nitrile Examination Gloves, Powder Free
- Model / Reference
- EM0102, Q1105EX
- Primary DI / UDI-DI
- 05206970070905
- Basic UDI-DI
- 69332655EM01021562864B
- Direct Marketing DI
- 05206970070905
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000001139
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Blue Sail Medical 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