Metal Optical Frames
by Wenzhou Robo Import & Export Co., Ltd EUDAMED
Active
Ref RTM-1205Model RTM3101,RTM-3102,RTM-3103,RTM-3104,RTM-3105,,RTM-4301,RTM-4302,RTM-4303,RTM-4304,RTM-4305,RTM-4306,RTM-4107,RTM-4108,RTM-4109,RTM-4110,RTM-4111,RTM-3201,RTM-3202,RTM-3203,RTM- 3204,RTM-3205,RTM-3206,RTM-4801,RTM-4802,RTM-4803,.RTM4804,RTM4805,RTM4806,etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6975196842200101VV | Date21 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Metal Optical Frames
- Model / Reference
- RTM3101, RTM-3102, RTM-3103, RTM-3104, RTM-3105, RTM-4301, RTM-4302, RTM-4303, RTM-4304, RTM-4305, RTM-4306, RTM-4107, RTM-4108, RTM-4109, RTM-4110, RTM-4111, RTM-3201, RTM-3202, RTM-3203, RTM- 3204, RTM-3205, RTM-3206, RTM-4801, RTM-4802, RTM-4803, .RTM4804, RTM4805, RTM4806, etc, RTM-1205
- Primary DI / UDI-DI
- 06975196842878
- Basic UDI-DI
- 6975196842200101VV
- EMDN Code
- Q02100201 Metal spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Hungary
Manufacturer details
- EUDAMED SRN
- CN-MF-000015287
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wenzhou Robo Import & Export Co., Ltd
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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