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Optical Frames
EUDAMEDClass I (EU MDR)
Ref LEVANTBKRDModel Plastic full rimRef MISTRALBLPKRef TERRALGYORRef MISTRALPKBLRef MISTRALGYPKRef BORAWHRDRef TERRALBKRD
Identity
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- Plastic full rim EUDAMEDLEVANTBKRD EUDAMEDMISTRALBLPK EUDAMEDTERRALGYOR EUDAMEDMISTRALPKBL EUDAMEDMISTRALGYPK EUDAMEDBORAWHRD EUDAMEDTERRALBKRD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977944420031 EUDAMED06977944420178 EUDAMED06977944420086 EUDAMED06977944420161 EUDAMED06977944420154 EUDAMED06977944420024 EUDAMED06977944420062 EUDAMED
- Basic UDI-DI
- 697794442OPFZ7 EUDAMED
- Direct Marketing DI
- 06977944420031 EUDAMED06977944420178 EUDAMED06977944420086 EUDAMED06977944420161 EUDAMED06977944420154 EUDAMED06977944420024 EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Optical Frames by Wenzhou Kaibang 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 | 697794442OPFZ7 | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Kaibang Optical Co., Ltd
- EUDAMED SRN
- CN-MF-000018328
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (7)
- EUDAMED d5774d59-3100-4796-97f3-40fd9cc754a9 61 fields · synced Sep 18, 2026
- EUDAMED bc90869a-196e-4725-865f-9146ebdeb0e9 61 fields · synced May 17, 2026
- EUDAMED cc573098-28ad-462f-9a7d-c25e616b2f44 61 fields · synced May 18, 2026
- EUDAMED 7a05fe68-616f-415d-b2f5-7b383a9451b4 61 fields · synced May 18, 2026
- EUDAMED af1af9f8-d4cf-46d3-92f6-cf65646cf0d5 61 fields · synced May 18, 2026
- EUDAMED 78b9d345-2c57-4776-a6b0-bb420569c727 61 fields · synced May 18, 2026
- EUDAMED 294def98-7271-42cb-bbc5-ac798e02fe15 61 fields · synced May 18, 2026