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Cold light source
EUDAMEDClass I (EU MDR)
Ref AGS-PL100Model AGS210、AGS200、AGS100、AGS-PL100Ref AGS100Ref AGS220Ref AGS210Ref AGS200
Identity
- Trade Name
- Cold light source EUDAMED
- Device Name
- Cold light source EUDAMED
- Model / Reference
- AGS210、AGS200、AGS100、AGS-PL100 EUDAMEDAGS-PL100 EUDAMEDAGS100 EUDAMEDAGS220 EUDAMEDAGS210 EUDAMEDAGS200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975465800066 EUDAMED06975465800011 EUDAMED06975465800172 EUDAMED06975465800059 EUDAMED06975465800028 EUDAMED
- Basic UDI-DI
- 697546580AGSCLSS5 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Endoscopic light source unit, line-powered
Cold light source by Wuzhou Aokace Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697546580AGSCLSS5 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuzhou Aokace Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027213
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED cbc08b34-9080-4619-9b14-86aa0113b766 61 fields · synced Sep 17, 2026
- EUDAMED 1d0d4552-b927-460c-a593-49a304e9a4ee 61 fields · synced May 17, 2026
- EUDAMED 13b20786-5888-4219-a758-642660fb43e4 61 fields · synced May 17, 2026
- EUDAMED 1fc15882-1421-49e7-b5ea-196f336f531f 61 fields · synced May 18, 2026
- EUDAMED 37b44364-222a-479d-8cb9-a14af3625ee5 61 fields · synced May 18, 2026