Topacio +3.50
by Wenzhou Hieasy Imp. &Exp. Co. Ltd. China EUDAMED
Ref Topacio +3.50
EMDN Y210324
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697840604readingglasses53 | Date16 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Reading glasses
- Model / Reference
- Topacio +3.50
- Primary DI / UDI-DI
- 08435607217384
- Basic UDI-DI
- 697840604readingglasses53
- Direct Marketing DI
- 08435607217384
- EMDN Code
- Y210324 Near sightedness telescopic systems/spectacles
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000042826
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wenzhou Hieasy Imp. &Exp. Co. Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED d0faced0-8001-4a39-8e4f-2359020f4733