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Reading Glasses
EUDAMEDClass I (EU MDR)
Ref 976450400339Model FH2106-032/FH908 -033/FH1486-034/FH2107-035/FH1209-2-036
Identity
- Device Name
- READING GLASSES EUDAMED
- Model / Reference
- FH2106-032/FH908 -033/FH1486-034/FH2107-035/FH1209-2-036 EUDAMED976450400339 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976450400322 EUDAMED
- Basic UDI-DI
- 697645040RDFH1LH EUDAMED
- Direct Marketing DI
- 06976450400322 EUDAMED
- EMDN Code
- Q0210010202 MULTIFOCAL MINERAL OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Reading Glasses by Wenzhou Sunbest Optical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697645040RDFH1LH | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Sunbest Optical Co., Ltd.
- EUDAMED SRN
- CN-MF-000034228
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 222d08c7-db3d-4958-a20c-39f9252e87c7 61 fields · synced Jun 18, 2026