Identity
- Trade Name
- 4K ALL-IN-ONE ENDOSCOPE EUDAMED
- Device Name
- 4K all-in-one endoscope camera system EUDAMED
- Model / Reference
- AGM-UHD3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975465800158 EUDAMED
- Basic UDI-DI
- 697546580AGSUHD33T EUDAMED
- EMDN Code
- Z11039010 PHOTO CAMERAS 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 All-In-One Endoscope 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 | 697546580AGSUHD33T | 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 (1)
- EUDAMED 472e9e09-1bb6-4c9c-8075-37f502adccec 61 fields · synced Jul 12, 2026