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Eyewear
EUDAMEDClass I (EU MDR)
Ref PLASTIC OPTICAL FRAMEModel PLASTIC OPTICAL FRAME, METAL OPTICAL FRAME Ref METAL OPTICAL FRAME
Identity
- Device Name
- EYEWEAR EUDAMED
- Model / Reference
- PLASTIC OPTICAL FRAME, METAL OPTICAL FRAME EUDAMEDPLASTIC OPTICAL FRAME EUDAMEDMETAL OPTICAL FRAME EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897154190017 EUDAMED04897154200020 EUDAMED
- Basic UDI-DI
- 489715419eyewearNG EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMEDQ02100201 METAL SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Eyewear by Abba Optical Company 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 | 489715419eyewearNG | Class I | Active |
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Manufacturer
- Manufacturer
- Abba Optical Company Limited
- EUDAMED SRN
- HK-MF-000052296
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 12794303-8afd-455b-a69e-a062ac66a716 61 fields · synced Jul 31, 2026
- EUDAMED 3a97c460-2772-487f-ad74-12854d76ac01 61 fields · synced May 18, 2026