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4k Endoscope Camera System
EUDAMEDClass I (EU MDR)
Ref AGM UHD1EModel AGM UHD1、AGM UHD1T、AGM UHD1ERef AGM UHD1
Identity
- Trade Name
- 4K ENDOSCOPE CAMERA SYSTEM EUDAMED
- Device Name
- 4K ENDOSCOPE CAMERA SYSTEM EUDAMED
- Model / Reference
- AGM UHD1、AGM UHD1T、AGM UHD1E EUDAMEDAGM UHD1E EUDAMEDAGM UHD1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975465800141 EUDAMED06975465800127 EUDAMED
- Basic UDI-DI
- 697546580AGSUHD13P EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
4k Endoscope Camera System by Wuzhou Aokace Technology 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 | 697546580AGSUHD13P | 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 (2)
- EUDAMED 441622f5-884a-42b0-8f56-789d64086b18 61 fields · synced Jul 26, 2026
- EUDAMED 2e8775b4-ef0c-48ce-ba61-fd1fb2b5bacb 61 fields · synced May 17, 2026