Optical frame
by Plus Eyewear Limited 474 variants
Ref SD02-FTModel CA-101A,R16A-HN,R16A-FA,R16A-HJ,R16A-AA,R17A-HK,R17A-HL,R17A-HM,R17A-HP,R18A-HQ,R18A-HR,R18A-HS,R18A-AC,R19A-6W,R19A-6V,R19A-28,R19A-1D,R20A-6V,R20A-35,R20A-3Y,R20A-0Y,R21A-3V,R21A-0Z,R21A-00,R21A-3C,etc
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 | Number489715020OF0019Z 04897150205852 | Date14 Oct 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- Withdrawn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
- Optical frame
- Model / Reference
- CA-101A, R16A-HN, R16A-FA, R16A-HJ, R16A-AA, R17A-HK, R17A-HL, R17A-HM, R17A-HP, R18A-HQ, R18A-HR, R18A-HS, R18A-AC, R19A-6W, R19A-6V, R19A-28, R19A-1D, R20A-6V, R20A-35, R20A-3Y, R20A-0Y, R21A-3V, R21A-0Z, R21A-00, R21A-3C, etc, SD02-FT
- Primary DI / UDI-DI
- 04897150205852
- Basic UDI-DI
- 489715020OF0019Z
- EMDN Code
- Q02100202 Plastic spectacle frames without lenses
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- HK-MF-000049624
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Plus Eyewear Limited
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