OraFlex
by Dongguan Globexy Intelligent Technology Co., Ltd EUDAMED
Active
Ref ORA-MED-011-S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697927247ORAMED0113U | Date4 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Dental Lip and Cheek Retractor
- Model / Reference
- ORA-MED-011-S
- Primary DI / UDI-DI
- 06979272470047
- Basic UDI-DI
- 697927247ORAMED0113U
- EMDN Code
- Q010599 Dental instruments, single-use - other
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000057426
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Dongguan Globexy Intelligent Technology 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