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Acetate Sunglasses
EUDAMEDClass I (EU MDR)
Ref 06978916010656Model KOM-S11178Ref 06978916010205Model KOM-S11477Ref 06978916011349Model KOM-S20702Ref 06978916010540Model KOM-S11875Ref 06978916011110Model KOM-X68900Ref 06978916011059Model KOM-S11654Ref 06978916010526Model KOM-S11850Ref 06978916010380Model KOM-S11600Ref 06978916010441Model KOM-S11627Ref 06978916010960Model KOM-S11504Ref 06978916010472Model KOM-S11651Ref 06978916010427Model KOM-S11625Ref 06978916010335Model KOM-S11553Ref 06978916010304Model KOM-S11550Ref 06978916010410Model KOM-S11603Ref 06978916011080Model KOM-X69900Ref 06978916011028Model KOM-S11579Ref 06978916010229Model KOM-S11500Ref 06978916010700Model KOM-S20550Ref 06978916010625Model KOM-S11150Ref 06978916010373Model KOM-S11578Ref 06978916010670Model KOM-S20251Ref 06978916010717Model KOM-S20551Ref 06978916010328Model KOM-S11552Ref 06978916011011Model KOM-S11529Ref 06978916010946Model KOM-S20302Ref 06978916010632Model KOM-S11151Ref 06978916011400Model KOM-S11580Ref 06978916010212Model KOM-S11478Ref 06978916011004Model KOM-S11179Ref 06978916010397Model KOM-S11601Ref 06978916011073Model KOM-X69700Ref 06978916010519Model KOM-S11826Ref 06978916011103Model KOM-X68700Ref 06978916010243Model KOM-S11502Ref 06978916010120Model KOM-S11176Ref 06978916010311Model KOM-S11551Ref 06978916011745Model KOM-S20304Ref 06978916011769Model KOM-S20927Ref 06978916011516Model KOM-S20775Ref 06978916011677Model KOM-S20750Ref 06978916011585Model KOM-S20803Ref 06978916011660Model KOM-S20728Ref 06978916011547Model KOM-S20778Ref 06978916011530Model KOM-S20777Ref 06978916011646Model KOM-S20726Ref 06978916011615Model KOM-S20827Ref 06978916011608Model KOM-S20826Ref 06978916011622Model KOM-S20828Ref 06978916011578Model KOM-S20802Ref 06978916011752Model KOM-S20926
Identity
- Trade Name
- ACETATE SUNGLASSES EUDAMED
- Device Name
- ACETATE SUNGLASSES EUDAMED
- Model / Reference
- KOM-S11178 EUDAMED06978916010656 EUDAMEDKOM-S11477 EUDAMED06978916010205 EUDAMEDKOM-S20702 EUDAMED06978916011349 EUDAMEDKOM-S11875 EUDAMED06978916010540 EUDAMEDKOM-X68900 EUDAMED06978916011110 EUDAMEDKOM-S11654 EUDAMED06978916011059 EUDAMEDKOM-S11850 EUDAMED06978916010526 EUDAMEDKOM-S11600 EUDAMED06978916010380 EUDAMEDKOM-S11627 EUDAMED06978916010441 EUDAMEDKOM-S11504 EUDAMED06978916010960 EUDAMEDKOM-S11651 EUDAMED06978916010472 EUDAMEDKOM-S11625 EUDAMED06978916010427 EUDAMEDKOM-S11553 EUDAMED06978916010335 EUDAMEDKOM-S11550 EUDAMED06978916010304 EUDAMEDKOM-S11603 EUDAMED06978916010410 EUDAMEDKOM-X69900 EUDAMED06978916011080 EUDAMEDKOM-S11579 EUDAMED06978916011028 EUDAMEDKOM-S11500 EUDAMED06978916010229 EUDAMEDKOM-S20550 EUDAMED06978916010700 EUDAMEDKOM-S11150 EUDAMED06978916010625 EUDAMEDKOM-S11578 EUDAMED06978916010373 EUDAMEDKOM-S20251 EUDAMED06978916010670 EUDAMEDKOM-S20551 EUDAMED06978916010717 EUDAMEDKOM-S11552 EUDAMED06978916010328 EUDAMEDKOM-S11529 EUDAMED06978916011011 EUDAMEDKOM-S20302 EUDAMED06978916010946 EUDAMEDKOM-S11151 EUDAMED06978916010632 EUDAMEDKOM-S11580 EUDAMED06978916011400 EUDAMEDKOM-S11478 EUDAMED06978916010212 EUDAMEDKOM-S11179 EUDAMED06978916011004 EUDAMEDKOM-S11601 EUDAMED06978916010397 EUDAMEDKOM-X69700 EUDAMED06978916011073 EUDAMEDKOM-S11826 EUDAMED06978916010519 EUDAMEDKOM-X68700 EUDAMED06978916011103 EUDAMEDKOM-S11502 EUDAMED06978916010243 EUDAMEDKOM-S11176 EUDAMED06978916010120 EUDAMEDKOM-S11551 EUDAMED06978916010311 EUDAMEDKOM-S20304 EUDAMED06978916011745 EUDAMEDKOM-S20927 EUDAMED06978916011769 EUDAMEDKOM-S20775 EUDAMED06978916011516 EUDAMEDKOM-S20750 EUDAMED06978916011677 EUDAMEDKOM-S20803 EUDAMED06978916011585 EUDAMEDKOM-S20728 EUDAMED06978916011660 EUDAMEDKOM-S20778 EUDAMED06978916011547 EUDAMEDKOM-S20777 EUDAMED06978916011530 EUDAMEDKOM-S20726 EUDAMED06978916011646 EUDAMEDKOM-S20827 EUDAMED06978916011615 EUDAMEDKOM-S20826 EUDAMED06978916011608 EUDAMEDKOM-S20828 EUDAMED06978916011622 EUDAMEDKOM-S20802 EUDAMED06978916011578 EUDAMEDKOM-S20926 EUDAMED06978916011752 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978916010656 EUDAMED06978916010205 EUDAMED06978916011349 EUDAMED06978916010540 EUDAMED06978916011110 EUDAMED06978916011059 EUDAMED06978916010526 EUDAMED06978916010380 EUDAMED06978916010441 EUDAMED06978916010960 EUDAMED06978916010472 EUDAMED06978916010427 EUDAMED06978916010335 EUDAMED06978916010304 EUDAMED06978916010410 EUDAMED06978916011080 EUDAMED06978916011028 EUDAMED06978916010229 EUDAMED06978916010700 EUDAMED06978916010625 EUDAMED06978916010373 EUDAMED06978916010670 EUDAMED06978916010717 EUDAMED06978916010328 EUDAMED06978916011011 EUDAMED06978916010946 EUDAMED06978916010632 EUDAMED06978916011400 EUDAMED06978916010212 EUDAMED06978916011004 EUDAMED06978916010397 EUDAMED06978916011073 EUDAMED06978916010519 EUDAMED06978916011103 EUDAMED06978916010243 EUDAMED06978916010649 EUDAMED06978916010311 EUDAMED06978916011745 EUDAMED06978916011769 EUDAMED06978916011516 EUDAMED06978916011677 EUDAMED06978916011585 EUDAMED06978916011660 EUDAMED06978916011547 EUDAMED06978916011530 EUDAMED06978916011646 EUDAMED06978916011615 EUDAMED06978916011608 EUDAMED06978916011622 EUDAMED06978916011578 EUDAMED06978916011752 EUDAMED
- Basic UDI-DI
- 697891601178PX EUDAMED697891601477QC EUDAMED697891601207026U EUDAMED697891601875QU EUDAMED697891601X68900JH EUDAMED6978916011165476 EUDAMED697891601850QC EUDAMED697891601600PK EUDAMED697891601627Q7 EUDAMED697891601115046J EUDAMED697891601651Q4 EUDAMED697891601625Q3 EUDAMED697891601553Q3 EUDAMED697891601550PV EUDAMED697891601603PR EUDAMED697891601X69900JQ EUDAMED697891601115797H EUDAMED697891601500PE EUDAMED697891601205P9 EUDAMED697891601150P9 EUDAMED697891601578QK EUDAMED697891601251PG EUDAMED697891601206PB EUDAMED697891601552PZ EUDAMED6978916011152972 EUDAMED6978916012030268 EUDAMED697891601151PB EUDAMED6978916011158072 EUDAMED697891601478QE EUDAMED697891601111796V EUDAMED697891601601PM EUDAMED697891601X69700JE EUDAMED697891601826QF EUDAMED697891601X68700J7 EUDAMED697891601502PJ EUDAMED697891601176PT EUDAMED697891601551PX EUDAMED697891601203046C EUDAMED697891601209277N EUDAMED697891601207757P EUDAMED6978916012075077 EUDAMED6978916012080373 EUDAMED697891601207287E EUDAMED697891601207787V EUDAMED697891601207777T EUDAMED697891601207267A EUDAMED697891601208277H EUDAMED697891601208267F EUDAMED697891601208287K EUDAMED697891601208026Z EUDAMED697891601209267L EUDAMED
- Direct Marketing DI
- 06978916010656 EUDAMED06978916010205 EUDAMED06978916011349 EUDAMED06978916010540 EUDAMED06978916011110 EUDAMED06978916011059 EUDAMED06978916010526 EUDAMED06978916010380 EUDAMED06978916010441 EUDAMED06978916010960 EUDAMED06978916010472 EUDAMED06978916010427 EUDAMED06978916010335 EUDAMED06978916010304 EUDAMED06978916010410 EUDAMED06978916011080 EUDAMED06978916011028 EUDAMED06978916010229 EUDAMED06978916010700 EUDAMED06978916010625 EUDAMED06978916010373 EUDAMED06978916010670 EUDAMED06978916010717 EUDAMED06978916010328 EUDAMED06978916011011 EUDAMED06978916010946 EUDAMED06978916010632 EUDAMED06978916011400 EUDAMED06978916010212 EUDAMED06978916011004 EUDAMED06978916010397 EUDAMED06978916011073 EUDAMED06978916010519 EUDAMED06978916011103 EUDAMED06978916010243 EUDAMED06978916010649 EUDAMED06978916010311 EUDAMED06978916011745 EUDAMED06978916011769 EUDAMED06978916011516 EUDAMED06978916011677 EUDAMED06978916011585 EUDAMED06978916011660 EUDAMED06978916011547 EUDAMED06978916011530 EUDAMED06978916011646 EUDAMED06978916011615 EUDAMED06978916011608 EUDAMED06978916011622 EUDAMED06978916011578 EUDAMED06978916011752 EUDAMED
- EMDN Code
- Q0210030199 READY TO WEAR SPECTACLES WITH ORGANIC LENSES - OTHER 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
Acetate Sunglasses by Wenzhou New Standing Eyewear 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 | 697891601178PX | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou New Standing Eyewear Co., Ltd.
- EUDAMED SRN
- CN-MF-000030477
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (51)
- EUDAMED 27f46a28-589c-4edb-b2fa-f0de310414e7 61 fields · synced Oct 6, 2026
- EUDAMED 652bc797-7f90-4f1b-b520-fc92113744e7 61 fields · synced May 11, 2026
- EUDAMED 6aaf4b94-e244-42d1-92d1-e7d1b3d7bea6 61 fields · synced May 11, 2026
- EUDAMED af406cc8-e020-4c58-ba0c-a55241e2e2f9 61 fields · synced May 11, 2026
- EUDAMED 905ec9a9-0410-4677-a100-aa661b488275 61 fields · synced May 16, 2026
- EUDAMED f125ac4b-b4b0-4142-9fdf-1607b81c7b4e 61 fields · synced May 16, 2026
- EUDAMED 842e51b6-7d6a-41a8-958b-eb75aa24a635 61 fields · synced May 16, 2026
- EUDAMED ea7f24eb-fa3e-4a5e-801b-01074e653655 61 fields · synced May 16, 2026
- EUDAMED af5633b4-637e-4521-884f-2f834f8d3e94 61 fields · synced May 16, 2026
- EUDAMED 1304c5fd-36e1-40a5-a517-8f1f05a4bcf2 61 fields · synced May 17, 2026
- EUDAMED fdeefd4a-3622-4fa1-9fa3-dae8aff4bfec 61 fields · synced May 17, 2026
- EUDAMED 539ef826-3514-4b33-9aab-e9b0a1bb4875 61 fields · synced May 17, 2026
- EUDAMED 48a01f5a-33b0-458e-a43d-1c25b789bfea 61 fields · synced May 17, 2026
- EUDAMED 40c64471-cf25-442e-9bbb-8d56a67f851a 61 fields · synced May 17, 2026
- EUDAMED 88d7530b-5098-4f34-ab1d-439912785eff 61 fields · synced May 17, 2026
- EUDAMED 2247a63b-7f2e-45d9-a2f0-be4715a53b3b 61 fields · synced May 17, 2026
- EUDAMED c813a30f-c543-44bf-bd8d-39cc30af4089 61 fields · synced May 17, 2026
- EUDAMED 7bf3e12e-ad9d-462b-8e5d-ed37a13eec06 61 fields · synced May 17, 2026
- EUDAMED a589dc67-965c-4abb-9e04-5765f0612a36 61 fields · synced May 17, 2026
- EUDAMED 22f56d01-05ac-42ea-9255-12e788557fcd 61 fields · synced May 18, 2026
- EUDAMED b19bedc5-e203-4b81-9304-d589cc2051b7 61 fields · synced May 18, 2026
- EUDAMED 37fd15b9-f214-4d6d-827b-857de9d31cd8 61 fields · synced May 18, 2026
- EUDAMED c2c6be53-8cc1-4610-9d83-aee451910cd3 61 fields · synced May 18, 2026
- EUDAMED e94f8584-7379-4d97-a5bb-9fa2f13d72d7 61 fields · synced May 18, 2026
- EUDAMED 8fead173-c0a6-40c0-9920-b3014fed83a8 61 fields · synced May 18, 2026
- EUDAMED 30c6a5cb-e5b6-45b7-a62e-dd783ff96116 61 fields · synced May 18, 2026
- EUDAMED 6f815c53-52b0-49d0-9056-dc8123d1033f 61 fields · synced May 18, 2026
- EUDAMED 7e2e8d3e-0f99-4bc5-9b71-10ac41b02597 61 fields · synced May 18, 2026
- EUDAMED 219e91e3-b5c1-4cb6-8b59-9aa5298083a0 61 fields · synced May 18, 2026
- EUDAMED 2f043dbb-da90-4739-a717-ee7ae2ec0cd1 61 fields · synced May 18, 2026
- EUDAMED 3a028c97-ef73-487c-91bb-3cb6ef68cb03 61 fields · synced May 18, 2026
- EUDAMED 3d4cd0f8-6309-48c2-8e9b-444bb78050a0 61 fields · synced May 18, 2026
- EUDAMED 8549c12a-a8dd-4904-a9e4-b721512992d2 61 fields · synced May 18, 2026
- EUDAMED c510c7be-de9c-4e68-aaf4-708475ec2ded 61 fields · synced May 18, 2026
- EUDAMED b6d6df2d-3c3c-4c07-8e0c-451d164a2226 61 fields · synced May 18, 2026
- EUDAMED e273ad92-5acc-40f6-81f6-1e18a6038df0 61 fields · synced May 19, 2026
- EUDAMED bfd149c0-645c-4341-a64f-1718cb10a73e 61 fields · synced May 19, 2026
- EUDAMED d8870ab4-7b7e-469b-b1cd-68d8cd091b7a 61 fields · synced Jun 18, 2026
- EUDAMED bc9323d6-bb6f-46f0-94ba-34f7941ae1d2 61 fields · synced Jul 9, 2026
- EUDAMED 5744a77b-6da9-4e93-a842-732d52874a04 61 fields · synced Jul 9, 2026
- EUDAMED 3468108c-936b-4840-ab18-ee97996d2221 61 fields · synced Jul 9, 2026
- EUDAMED 72ec9f5b-5b33-474c-ae36-eca138b7b3a5 61 fields · synced Jul 12, 2026
- EUDAMED e1a7ff90-7c25-4c40-87f9-67d4fec841fd 61 fields · synced Jul 12, 2026
- EUDAMED 59f9ffad-cee7-4c7d-8f5d-ee688de41fbf 61 fields · synced Jul 13, 2026
- EUDAMED abcb98da-7db3-4444-97cf-e395ac1cb1f6 61 fields · synced Jul 14, 2026
- EUDAMED bab302e7-f1dd-4329-a73f-1714bb40ffaa 61 fields · synced Jul 20, 2026
- EUDAMED 3e1f30f7-4627-42b9-91e8-97f8f0622f17 61 fields · synced Jul 28, 2026
- EUDAMED 702846a9-b1f6-4d01-8150-cec570922aac 61 fields · synced Jul 28, 2026
- EUDAMED aa05ea50-bf4a-4995-86ae-5d5cd6e26c9d 61 fields · synced Jul 29, 2026
- EUDAMED 6af93796-ef12-4ab1-9f66-652e88a33b9c 61 fields · synced Jul 30, 2026
- EUDAMED d117d433-5f41-499e-8f0f-ee32c3dbbd32 61 fields · synced Jul 30, 2026