Protect
by Zhejiang Protect Medical Equipment Co., Ltd. 5 variants
Ref Pure Ceramic ROTH Bracket 0.022 (5-5) 345w/hook, Lingual Button Round, Q010402, 4002-1
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69364670007WB | Date9 May 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- ProtectLingual Button Round
- Device Name
- Orthodontic Ceramic BracketsOrthodontic Lingual ButtonsOrthodontic Bands
- Model / Reference
- Pure Ceramic ROTH Bracket 0.022 (5-5) 345w/hook, Lingual Button Round, Q010402, 4002-1
- Primary DI / UDI-DI
- 06936467008355, 06936467080047, 06936467046012
- Basic UDI-DI
- 69364670007WB, 69364670005W7, 69364670002VZ, B-06936467080047
- Direct Marketing DI
- 069364670083550693646708004706936467046012
- EMDN Code
- Q010403, Q010402
- Device Class
- Class IIa
- EU market of registration
- PolandFrance
Manufacturer details
- EUDAMED SRN
- CN-MF-000023282
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Zhejiang Protect Medical Equipment Co., Ltd.
See all devices from Zhejiang Protect Medical Equipment 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