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Optical Frames
EUDAMEDClass I (EU MDR)
Ref 06978916011202Model KOM-O10627Ref 06978916010892Model KOM-O10225Ref 06978916011448Model KOM-O10827Ref 06978916010830Model KOM-O10026Ref 06978916011042Model KOM-O10029Ref 06978916010915Model KOM-O10227Ref 06978916010045Model KOM-O9051Ref 06978916011295Model KOM-O10500Ref 06978916010762Model KOM-O10301Ref 06978916010809Model KOM-O10000Ref 06978916011196Model KOM-O10626Ref 06978916011264Model KOM-O10475Ref 06978916011301Model KOM-O10501Ref 06978916010021Model KOM-O9027Ref 06978916010823Model KOM-O10002Ref 06978916011257Model KOM-O10653Ref 06978916010601Model KOM-O9000Ref 06978916010038Model KOM-O9050Ref 06978916010724Model KOM-O10275Ref 06978916011226Model KOM-O10650Ref 06978916010847Model KOM-O10027Ref 06978916010885Model KOM-O10202Ref 06978916011462Model KOM-O10451Ref 06978916011714Model KOM-O9080
Identity
- Trade Name
- OPTICAL FRAMES EUDAMED
- Device Name
- OPTICAL FRAMES EUDAMED
- Model / Reference
- KOM-O10627 EUDAMED06978916011202 EUDAMEDKOM-O10225 EUDAMED06978916010892 EUDAMEDKOM-O10827 EUDAMED06978916011448 EUDAMEDKOM-O10026 EUDAMED06978916010830 EUDAMEDKOM-O10029 EUDAMED06978916011042 EUDAMEDKOM-O10227 EUDAMED06978916010915 EUDAMEDKOM-O9051 EUDAMED06978916010045 EUDAMEDKOM-O10500 EUDAMED06978916011295 EUDAMEDKOM-O10301 EUDAMED06978916010762 EUDAMEDKOM-O10000 EUDAMED06978916010809 EUDAMEDKOM-O10626 EUDAMED06978916011196 EUDAMEDKOM-O10475 EUDAMED06978916011264 EUDAMEDKOM-O10501 EUDAMED06978916011301 EUDAMEDKOM-O9027 EUDAMED06978916010021 EUDAMEDKOM-O10002 EUDAMED06978916010823 EUDAMEDKOM-O10653 EUDAMED06978916011257 EUDAMEDKOM-O9000 EUDAMED06978916010601 EUDAMEDKOM-O9050 EUDAMED06978916010038 EUDAMEDKOM-O10275 EUDAMED06978916010724 EUDAMEDKOM-O10650 EUDAMED06978916011226 EUDAMEDKOM-O10027 EUDAMED06978916010847 EUDAMEDKOM-O10202 EUDAMED06978916010885 EUDAMEDKOM-O10451 EUDAMED06978916011462 EUDAMEDKOM-O9080 EUDAMED06978916011714 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978916011202 EUDAMED06978916010892 EUDAMED06978916011448 EUDAMED06978916010830 EUDAMED06978916011042 EUDAMED06978916010915 EUDAMED06978916010045 EUDAMED06978916011295 EUDAMED06978916010762 EUDAMED06978916010809 EUDAMED06978916011196 EUDAMED06978916011264 EUDAMED06978916011301 EUDAMED06978916010021 EUDAMED06978916010823 EUDAMED06978916011257 EUDAMED06978916010601 EUDAMED06978916010038 EUDAMED06978916010724 EUDAMED06978916011226 EUDAMED06978916010847 EUDAMED06978916010885 EUDAMED06978916011462 EUDAMED06978916011714 EUDAMED
- Basic UDI-DI
- 697891601106276U EUDAMED697891601225PF EUDAMED6978916011082776 EUDAMED697891601026P7 EUDAMED6978916011002962 EUDAMED697891601227PK EUDAMED697891601051P6 EUDAMED6978916011050063 EUDAMED697891601301P6 EUDAMED697891601100NS EUDAMED697891601106266S EUDAMED697891601104756V EUDAMED6978916011050165 EUDAMED697891601027P9 EUDAMED697891601003NT EUDAMED697891601106536V EUDAMED697891601000NM EUDAMED697891601050P4 EUDAMED697891601102NW EUDAMED697891601106506P EUDAMED697891601127PE EUDAMED697891601202P3 EUDAMED697891601104516F EUDAMED6978916019080GJ EUDAMED
- Direct Marketing DI
- 06978916011202 EUDAMED06978916010892 EUDAMED06978916011448 EUDAMED06978916010830 EUDAMED06978916011042 EUDAMED06978916010915 EUDAMED06978916010045 EUDAMED06978916011295 EUDAMED06978916010762 EUDAMED06978916010809 EUDAMED06978916011196 EUDAMED06978916011264 EUDAMED06978916011301 EUDAMED06978916010021 EUDAMED06978916010823 EUDAMED06978916011257 EUDAMED06978916010601 EUDAMED06978916010038 EUDAMED06978916010724 EUDAMED06978916011226 EUDAMED06978916010847 EUDAMED06978916010885 EUDAMED06978916011462 EUDAMED06978916011714 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 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 | 697891601106276U | 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 (24)
- EUDAMED 2441eca3-229d-407e-8578-a8378bb49376 61 fields · synced Oct 6, 2026
- EUDAMED ccee80da-652b-4b0f-9dc8-4b6ec0b9be7d 61 fields · synced May 17, 2026
- EUDAMED 8a784fae-362a-43c1-a32e-747c3a77d54c 61 fields · synced May 17, 2026
- EUDAMED 65976ac7-cea8-4518-865a-df463f61ae75 61 fields · synced May 17, 2026
- EUDAMED 46e17842-60ab-498c-be46-d7e0a9a7737c 61 fields · synced May 17, 2026
- EUDAMED bd9c526f-78c5-4e4b-8458-8021fa9f628f 61 fields · synced May 17, 2026
- EUDAMED 24e66e9a-2140-464f-b2aa-ba488424ade1 61 fields · synced May 17, 2026
- EUDAMED 002b3c47-a205-4e13-869f-1a0319b7691a 61 fields · synced May 18, 2026
- EUDAMED e7bfd3b5-bcd7-47fe-af3c-1511e61963b0 61 fields · synced May 18, 2026
- EUDAMED 04eb3e25-f630-4e89-950b-416381ac3b18 61 fields · synced May 18, 2026
- EUDAMED 00d3527d-19be-4e05-a68d-13090e6178bb 61 fields · synced May 18, 2026
- EUDAMED 8879c392-417d-4251-b843-442373a80bfb 61 fields · synced May 18, 2026
- EUDAMED 4d7c6c12-6634-4762-b331-f30ef3749697 61 fields · synced May 18, 2026
- EUDAMED 78cb69ed-acec-497f-8cb7-63b05d9cb625 61 fields · synced May 18, 2026
- EUDAMED aac4d733-b6ac-4322-a316-451c7fd43372 61 fields · synced May 18, 2026
- EUDAMED aa5e19e4-4c54-4c90-b889-00207b9708b1 61 fields · synced May 18, 2026
- EUDAMED 949e0cab-2e17-4c25-a05e-35340c9e1c10 61 fields · synced May 18, 2026
- EUDAMED bbadd612-b966-4d66-8a39-2987e9a9084a 61 fields · synced May 19, 2026
- EUDAMED 79e9939c-9323-46c2-a94b-f8bcaa5c841a 61 fields · synced May 19, 2026
- EUDAMED 6b701b34-e104-4e56-b4fa-928250570eff 61 fields · synced May 19, 2026
- EUDAMED 9ca07379-f38c-4135-a2e1-f5222620ca97 61 fields · synced May 19, 2026
- EUDAMED 09cf5bf5-ad6e-4822-ba9c-d57d3664318b 61 fields · synced May 19, 2026
- EUDAMED 8543ea28-f868-4d4a-9cee-9ac0c76e6c52 61 fields · synced Jul 18, 2026
- EUDAMED 95acdc18-4e26-40ab-b7bc-dd82ed468304 61 fields · synced Jul 28, 2026