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Optical Frames
EUDAMEDClass I (EU MDR)
Ref 06978985190044Model KOM-O8903 Aria Rose Gold SageRef 06978985190099Model KOM-O8878 Clara White Gold BurgundyRef 06978985190105Model KOM-O8877 Clara BlackRef 06978985190006Model KOM-O8928 Selena White Gold BlackRef 06978985190020Model KOM-O8926 Selena SilverRef 06978985190075Model KOM-O8900 Aria White GoldRef 06978985190037Model KOM-O8925 Selena GoldRef 06978985190129Model KOM-O8927 Selena Rose GoldRef 06978985190068Model KOM-O8901 Aria Black
Identity
- Trade Name
- OPTICAL FRAMES EUDAMED
- Device Name
- OPTICAL FRAMES EUDAMED
- Model / Reference
- KOM-O8903 Aria Rose Gold Sage EUDAMED06978985190044 EUDAMEDKOM-O8878 Clara White Gold Burgundy EUDAMED06978985190099 EUDAMEDKOM-O8877 Clara Black EUDAMED06978985190105 EUDAMEDKOM-O8928 Selena White Gold Black EUDAMED06978985190006 EUDAMEDKOM-O8926 Selena Silver EUDAMED06978985190020 EUDAMEDKOM-O8900 Aria White Gold EUDAMED06978985190075 EUDAMEDKOM-O8925 Selena Gold EUDAMED06978985190037 EUDAMEDKOM-O8927 Selena Rose Gold EUDAMED06978985190129 EUDAMEDKOM-O8901 Aria Black EUDAMED06978985190068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978985190044 EUDAMED06978985190099 EUDAMED06978985190105 EUDAMED06978985190006 EUDAMED06978985190020 EUDAMED06978985190075 EUDAMED06978985190037 EUDAMED06978985190129 EUDAMED06978985190068 EUDAMED
- Basic UDI-DI
- 697898519O8903ST EUDAMED697898519O8878TM EUDAMED697898519O8877TK EUDAMED697898519KOM4R EUDAMED697898519O8926T7 EUDAMED697898519O8900SM EUDAMED697898519O8925T5 EUDAMED697898519O8927T9 EUDAMED697898519O8901SP EUDAMED
- Direct Marketing DI
- 06978985190044 EUDAMED06978985190099 EUDAMED06978985190105 EUDAMED06978985190006 EUDAMED06978985190020 EUDAMED06978985190075 EUDAMED06978985190037 EUDAMED06978985190129 EUDAMED06978985190068 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Ray Jet Optical Limited — 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 | 697898519O8903ST | Class I | Active |
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Manufacturer
- Manufacturer
- Ray Jet Optical Limited
- EUDAMED SRN
- CN-MF-000047061
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (9)
- EUDAMED 3b4431c7-334f-40f9-ae17-b8837fa051f4 61 fields · synced Sep 18, 2026
- EUDAMED c9443161-1518-47ac-b056-57c0680e3027 61 fields · synced May 17, 2026
- EUDAMED ed864522-c481-4f78-952a-552ec3d1a316 61 fields · synced May 17, 2026
- EUDAMED 6ec1230b-680f-4f80-b3be-46b8c1a7c184 61 fields · synced May 17, 2026
- EUDAMED b86b2163-4975-4b67-84a9-8384aaca7281 61 fields · synced May 18, 2026
- EUDAMED 11228dc8-ebea-4c8e-bea5-6a932b36111b 61 fields · synced May 18, 2026
- EUDAMED ec973466-61bf-4afe-b07a-94c3549e7be8 61 fields · synced May 18, 2026
- EUDAMED e673d8cf-50c1-40c8-98e7-d5589eafe9f7 61 fields · synced May 18, 2026
- EUDAMED 8b84e397-cbe2-4c68-b1e6-1d349ec114b4 61 fields · synced May 18, 2026