Disposable Eyeshield
by Huanghua Promisee Dental Co.Ltd. 2 variants
Ref DE01Model FF01,FF04,FF04A,FF05,DE01,FF0102,FF0502,SG01,SG02,SG03,SG04, SG06,SG08,SG08A,SG09,YK03,
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 | Number69544540SGFS001US 06954454010907 | Date18 Mar 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- Withdrawn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
- Patient Protective Device
- Model / Reference
- FF01, FF04, FF04A, FF05, DE01, FF0102, FF0502, SG01, SG02, SG03, SG04, SG06, SG08, SG08A, SG09, YK03
- Primary DI / UDI-DI
- 06954454010907
- Basic UDI-DI
- 69544540SGFS001US
- EMDN Code
- Q0199 Odontology devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000014766
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Huanghua Promisee Dental 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