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Optical Frames
EUDAMEDClass I (EU MDR)
Ref 2Model MF04Model MF03Ref 1Model PF03Model MF02Model MF01Model AF01Model PF01
Identity
- Trade Name
- Optical Frames EUDAMED
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- MF04 EUDAMED2 EUDAMEDMF03 EUDAMEDPF03 EUDAMED1 EUDAMEDMF02 EUDAMEDMF01 EUDAMEDAF01 EUDAMEDPF01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976215590077 EUDAMED06976215590060 EUDAMED06976215590107 EUDAMED06976215590053 EUDAMED06976215590046 EUDAMED06976215590015 EUDAMED06976215590084 EUDAMED
- Basic UDI-DI
- 6976215590077CB EUDAMED6976215590060BS EUDAMED6976215590107BT EUDAMED6976215590053BV EUDAMED6976215590046BY EUDAMED6976215590015BM EUDAMED6976215590084C8 EUDAMED
- Direct Marketing DI
- 06976215590077 EUDAMED06976215590060 EUDAMED06976215590107 EUDAMED06976215590053 EUDAMED06976215590046 EUDAMED06976215590015 EUDAMED06976215590084 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 101 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 | 6976215590077CB | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou 101 Optical Co., Ltd.
- EUDAMED SRN
- CN-MF-000034399
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (7)
- EUDAMED cd72dcc5-acc3-4d59-8893-76322906aed9 61 fields · synced Jul 24, 2026
- EUDAMED 51496ad9-ae8b-45fb-96dc-9972fa1d2ac2 61 fields · synced May 17, 2026
- EUDAMED 0c193951-4e7d-4371-8ae9-9172db8dd65d 61 fields · synced May 18, 2026
- EUDAMED 8a5551e0-0469-48fb-8ec0-1ec3f30fce11 61 fields · synced May 19, 2026
- EUDAMED bb809897-bdda-4f54-8cd4-94d4eb979232 61 fields · synced May 19, 2026
- EUDAMED cb94cfb7-45f4-433a-9213-1b3f18489e6a 61 fields · synced May 19, 2026
- EUDAMED 60d854dc-729c-48a9-91ad-132f718271df 61 fields · synced May 19, 2026