Medical Loupes
by Hefei Meita Medical Equipment Technology Co., Ltd 11 variants
Ref MTA350Model Model: MTA250, MTA350, MTC3.0, MTC4.0, MTC5.0, MTC6.0, MTI3.0, MTI4.0, MTI5.0, MTI6.0, MTI8.0
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 | Number697997875Loupes9K 06979978751013 | Date1 Jul 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- Withdrawn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
- Medical Loupes
- Model / Reference
- Model: MTA250, MTA350, MTC3.0, MTC4.0, MTC5.0, MTC6.0, MTI3.0, MTI4.0, MTI5.0, MTI6.0, MTI8.0
- Primary DI / UDI-DI
- 06979978751013
- Basic UDI-DI
- 697997875Loupes9K
- EMDN Code
- Q0199 Odontology devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000055407
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hefei Meita Medical Equipment Technology Co., Ltd
See all devices from Hefei Meita Medical Equipment 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