Dental Loupes
by Shenzhen Americuras Co., Ltd 3 variants
Ref Eyezoom 2XModel Eyezoom 2X, Eyezoom 2.5X,Eyezoom 3X,Eyezoom 3.5X, Eyezoom 4X ,Eyezoom 4.5X
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 | Number697820314DENTALLOUPESDJ 06978203142596 | Date15 Aug 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- Withdrawn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
- Dental Loupes
- Model / Reference
- Eyezoom 2X, Eyezoom 2.5X, Eyezoom 3X, Eyezoom 3.5X, Eyezoom 4X, Eyezoom 4.5X
- Primary DI / UDI-DI
- 06978203142596
- Basic UDI-DI
- 697820314DENTALLOUPESDJ
- EMDN Code
- Q0199 Odontology devices - other
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000048352
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Americuras 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