Zogear
by ZOGEAR Medical Co., Ltd. 64 variants
Ref IM005-2Model IM005-1,IM005-2,IM005-3,IM005-4,IM005-5,IM005-6,IM005-7
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 | Number697484312IM005G6 06974843121694 | Date6 Nov 2026 | 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- Withdrawn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
- Fluoride Foam Tray Dual Arch
- Model / Reference
- IM005-1, IM005-2, IM005-3, IM005-4, IM005-5, IM005-6, IM005-7
- Primary DI / UDI-DI
- 06974843121694
- Basic UDI-DI
- 697484312IM005G6
- EMDN Code
- Q010503 Impression material trays, single-use
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000012353
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from ZOGEAR 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