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Optical Frames
EUDAMEDClass I (EU MDR)
Ref TC#483Ref TC#455Ref TC#512Ref TOM#326Ref TC#480Ref TC#495Ref TC#463Ref FMO-094 C2Ref AB560 C1Ref AB561 C1Ref TC#456Ref AL-1566-134C15/04Ref TOM#320Ref AL-1566-135C12/04Ref TC#452Ref 11041537Ref TC#447Ref TC#489Ref TC#511Ref TOM#325Ref TC#491Ref TC#500Ref FMO-250 C2Ref 0534M/CAREYRef TOM#319Ref TC#502Ref TC#507Ref 0536M/BLUERef FMO-246 C1Ref 0535M/DARK GREENRef FMO-205 C4Ref TC#487Ref TC#492Ref TOM#327Ref AL-1566-131C04Ref TC#474Ref FMO-249 C1Ref FMO-246 C2Ref 0534M/DARK GREENRef AB562 C2Ref 11041531Ref TC#446Ref TC#459Ref PBG2809C14Ref AB563 C3Ref 0534M/BLACKRef TC#481Ref 11041540Ref AL-1566-133C01Ref TC#476Ref FMO-247 C2
Identity
- Trade Name
- Optical Frames EUDAMED
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- TC#483 EUDAMEDTC#455 EUDAMEDTC#512 EUDAMEDTOM#326 EUDAMEDTC#480 EUDAMEDTC#495 EUDAMEDTC#463 EUDAMEDFMO-094 C2 EUDAMEDAB560 C1 EUDAMEDAB561 C1 EUDAMEDTC#456 EUDAMEDAL-1566-134C15/04 EUDAMEDTOM#320 EUDAMEDAL-1566-135C12/04 EUDAMEDTC#452 EUDAMED11041537 EUDAMEDTC#447 EUDAMEDTC#489 EUDAMEDTC#511 EUDAMEDTOM#325 EUDAMEDTC#491 EUDAMEDTC#500 EUDAMEDFMO-250 C2 EUDAMED0534M/CAREY EUDAMEDTOM#319 EUDAMEDTC#502 EUDAMEDTC#507 EUDAMED0536M/BLUE EUDAMEDFMO-246 C1 EUDAMED0535M/DARK GREEN EUDAMEDFMO-205 C4 EUDAMEDTC#487 EUDAMEDTC#492 EUDAMEDTOM#327 EUDAMEDAL-1566-131C04 EUDAMEDTC#474 EUDAMEDFMO-249 C1 EUDAMEDFMO-246 C2 EUDAMED0534M/DARK GREEN EUDAMEDAB562 C2 EUDAMED11041531 EUDAMEDTC#446 EUDAMEDTC#459 EUDAMEDPBG2809C14 EUDAMEDAB563 C3 EUDAMED0534M/BLACK EUDAMEDTC#481 EUDAMED11041540 EUDAMEDAL-1566-133C01 EUDAMEDTC#476 EUDAMEDFMO-247 C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974384062050 EUDAMED06974384061763 EUDAMED06974384064672 EUDAMED06974384063842 EUDAMED06974384068847 EUDAMED06974384064535 EUDAMED06974384069790 EUDAMED06974384067031 EUDAMED06974384065860 EUDAMED06974384060896 EUDAMED06974384065617 EUDAMED06974384065532 EUDAMED06974384061091 EUDAMED06974384067093 EUDAMED06974384065457 EUDAMED06974384067727 EUDAMED06974384067468 EUDAMED06974384069356 EUDAMED06974384064122 EUDAMED06974384065365 EUDAMED06974384065259 EUDAMED06974384066249 EUDAMED06974384067857 EUDAMED06974384069738 EUDAMED06974384065600 EUDAMED06974384063859 EUDAMED06974384065815 EUDAMED06974384065235 EUDAMED06974384066638 EUDAMED06974384060735 EUDAMED06974384068304 EUDAMED06974384065983 EUDAMED06974384064917 EUDAMED06974384068038 EUDAMED06974384066843 EUDAMED06974384062005 EUDAMED06974384061183 EUDAMED06974384066546 EUDAMED06974384063873 EUDAMED06974384060094 EUDAMED06974384068762 EUDAMED06974384062920 EUDAMED06974384066027 EUDAMED06974384060995 EUDAMED06974384068410 EUDAMED06974384064528 EUDAMED06974384061657 EUDAMED06974384064153 EUDAMED06974384066294 EUDAMED06974384068656 EUDAMED06974384061664 EUDAMED
- Basic UDI-DI
- 697438406OPGLRU EUDAMED
- Direct Marketing DI
- 06974384062050 EUDAMED06974384061763 EUDAMED06974384064672 EUDAMED06974384063842 EUDAMED06974384068847 EUDAMED06974384064535 EUDAMED06974384069790 EUDAMED06974384067031 EUDAMED06974384065860 EUDAMED06974384060896 EUDAMED06974384065617 EUDAMED06974384065532 EUDAMED06974384061091 EUDAMED06974384067093 EUDAMED06974384065457 EUDAMED06974384067727 EUDAMED06974384067468 EUDAMED06974384069356 EUDAMED06974384064122 EUDAMED06974384065365 EUDAMED06974384065259 EUDAMED06974384066249 EUDAMED06974384067857 EUDAMED06974384069738 EUDAMED06974384065600 EUDAMED06974384063859 EUDAMED06974384065815 EUDAMED06974384065235 EUDAMED06974384066638 EUDAMED06974384060735 EUDAMED06974384068304 EUDAMED06974384065983 EUDAMED06974384064917 EUDAMED06974384068038 EUDAMED06974384066843 EUDAMED06974384062005 EUDAMED06974384061183 EUDAMED06974384066546 EUDAMED06974384063873 EUDAMED06974384060094 EUDAMED06974384068762 EUDAMED06974384062920 EUDAMED06974384066027 EUDAMED06974384060995 EUDAMED06974384068410 EUDAMED06974384064528 EUDAMED06974384061657 EUDAMED06974384064153 EUDAMED06974384066294 EUDAMED06974384068656 EUDAMED06974384061664 EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMEDQ02100201 METAL SPECTACLE FRAMES WITHOUT LENSES EUDAMEDQ02100203 METAL AND 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 Innovision 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 | 697438406OPGLRU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wenzhou Innovision Optical Co., Ltd
- EUDAMED SRN
- CN-MF-000009602
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (51)
- EUDAMED 642b2f94-487c-4e64-bb40-057331ab8c0f 61 fields · synced Oct 6, 2026
- EUDAMED b79453a2-a05d-4adf-a915-353602ba1481 61 fields · synced May 11, 2026
- EUDAMED d599b8f6-6382-4a27-bc5f-0c99dbca4fdf 61 fields · synced May 11, 2026
- EUDAMED 07c00c70-0fc5-4e65-ada6-9195a9e6109e 61 fields · synced May 11, 2026
- EUDAMED 0dcc610c-5399-4556-8ab7-2d4e9c84678c 61 fields · synced May 11, 2026
- EUDAMED 1621587c-c851-44da-a474-14b31e398da8 61 fields · synced May 11, 2026
- EUDAMED c0741ad4-0b6e-4332-b3ff-ca0d4ffadc8f 61 fields · synced May 16, 2026
- EUDAMED 6411864d-b987-4c50-9f2d-84247a7674d4 61 fields · synced May 16, 2026
- EUDAMED a14eefe9-755a-4ca9-ab53-3525cfb97de7 61 fields · synced May 16, 2026
- EUDAMED 4b007d94-e508-492c-806a-9720784ed0e7 61 fields · synced May 16, 2026
- EUDAMED a018520c-c4d9-48de-93e1-2131e1bb951c 61 fields · synced May 16, 2026
- EUDAMED 7dd6294d-e4cb-4882-a723-823d912a84c3 61 fields · synced May 16, 2026
- EUDAMED ef409a6f-5fa9-4935-8462-03910d9db50b 61 fields · synced May 16, 2026
- EUDAMED 796bc9c4-5519-4cfa-b91f-b09bc9dfd72c 61 fields · synced May 16, 2026
- EUDAMED 81e224c3-35e8-4c14-963f-3b314dc0037e 61 fields · synced May 16, 2026
- EUDAMED 4d40c80a-0752-4f0d-bc9c-dc23c76e1475 61 fields · synced May 16, 2026
- EUDAMED 9748c1aa-3c71-4964-9959-1deb3936c626 61 fields · synced May 16, 2026
- EUDAMED 55f2ee97-dd60-4c14-9189-845664b9d14f 61 fields · synced May 16, 2026
- EUDAMED 83e9b29c-ad81-4fae-b453-cf541f548c22 61 fields · synced May 16, 2026
- EUDAMED 9537e12d-a5c1-46c9-8fb9-7bfc9ec8ea98 61 fields · synced May 16, 2026
- EUDAMED 1f61b08c-258f-4759-b3cb-9d8000921bf8 61 fields · synced May 16, 2026
- EUDAMED da71cd29-1556-4782-8263-2e0e7c4ee0f2 61 fields · synced May 17, 2026
- EUDAMED 3de741f2-2469-4957-a785-18d8871c8688 61 fields · synced May 17, 2026
- EUDAMED cd81e0da-8123-43c2-98e9-bb79d695c579 61 fields · synced May 17, 2026
- EUDAMED 593453e8-211e-48f9-9078-e0455a36acb8 61 fields · synced May 17, 2026
- EUDAMED c1c0de2f-c3ce-4238-93ff-df9f8617c0f7 61 fields · synced May 17, 2026
- EUDAMED f5945d5b-4d35-48c1-b3e0-795b864ae044 61 fields · synced May 17, 2026
- EUDAMED 19ff1871-a35a-45a6-85c3-36e83a9c898e 61 fields · synced May 17, 2026
- EUDAMED 839b586a-de05-4cf3-97e5-392723719fe3 61 fields · synced May 17, 2026
- EUDAMED 69ec70d9-5088-4b53-b287-1296288e5889 61 fields · synced May 17, 2026
- EUDAMED efbc37e8-2269-44e6-8779-47daf7f1c081 61 fields · synced May 17, 2026
- EUDAMED f136c77d-479a-4b7a-851f-4ab34a8403d9 61 fields · synced May 17, 2026
- EUDAMED 2253c579-d9dc-4327-8925-4a75a643cf47 61 fields · synced May 17, 2026
- EUDAMED 82cc2c76-0ca7-4bb2-a10a-a734613950ef 61 fields · synced May 17, 2026
- EUDAMED 38882c68-5df4-4040-a60e-8210c168afc4 61 fields · synced May 17, 2026
- EUDAMED d92dde43-3fd0-442c-9c33-ffadb51bb5cd 61 fields · synced May 17, 2026
- EUDAMED cbb6a17b-2f80-4572-b7b5-19eb1b7d47b8 61 fields · synced May 17, 2026
- EUDAMED 2d1f3863-8e68-4b90-87b9-fc453f285f0a 61 fields · synced May 17, 2026
- EUDAMED e483dea2-7762-400f-b45c-1ace9f9d58b3 61 fields · synced May 17, 2026
- EUDAMED 98ef9692-15df-4c46-ba46-5d69e61585e6 61 fields · synced May 17, 2026
- EUDAMED eebde225-79f0-403f-8362-f057766ca655 61 fields · synced May 17, 2026
- EUDAMED 0dfa354e-678e-4d24-84ab-9ed45956242a 61 fields · synced May 17, 2026
- EUDAMED 23051b37-c5f4-42f4-adfc-babf49a8a071 61 fields · synced May 17, 2026
- EUDAMED 653a63ba-d4a0-4344-a064-de339b98becd 61 fields · synced May 17, 2026
- EUDAMED 4e21373b-6c4a-44e2-aa7b-86bdb82569dc 61 fields · synced May 17, 2026
- EUDAMED cac16cd8-0e20-4d72-a2cb-c1f1a5c39eb9 61 fields · synced May 17, 2026
- EUDAMED c17a31d5-c93c-4446-afc8-632b711f4abb 61 fields · synced May 17, 2026
- EUDAMED d6ed5bfe-9b29-4c18-a983-d5e6731fd459 61 fields · synced May 17, 2026
- EUDAMED 229f007e-d781-4afc-b549-fa910fe32513 61 fields · synced May 17, 2026
- EUDAMED 6549a881-9c90-4aeb-994f-d2fba283301e 61 fields · synced May 17, 2026
- EUDAMED 0b4e3d5b-8214-43c1-9c21-99da94e45277 61 fields · synced May 17, 2026