Brighten Penlight
by Ningbo Brighten Longer Co., Ltd. 13 variants
Ref BR-PLA907Model BR-PLA901 BR-PLA902 BR-PLA903 BR-PLA904 BR-PLA905 BR-PLA906 BR-PLA907 BR-PLA908 BR-PLR301 BR-PLR302 BR-PLD101 BR-PLD102
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 | Number697639092PENLIGHTQW 06976390920065 | Date31 May 2023 | 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- Withdrawn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
- Penlight
- Model / Reference
- BR-PLA901 BR-PLA902 BR-PLA903 BR-PLA904 BR-PLA905 BR-PLA906 BR-PLA907 BR-PLA908 BR-PLR301 BR-PLR302 BR-PLD101 BR-PLD102, BR-PLA907
- Primary DI / UDI-DI
- 06976390920065
- Basic UDI-DI
- 697639092PENLIGHTQW
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000035205
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Ningbo Brighten Longer 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