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Endoscope camera and light source integrated
EUDAMEDClass I (EU MDR)
Ref AGM HD2
Identity
- Trade Name
- Endoscope camera and light source integrated EUDAMED
- Device Name
- Endoscope camera and light source integrated EUDAMED
- Model / Reference
- AGM HD2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975465800080 EUDAMED
- Basic UDI-DI
- 697546580AGSHD2Q6 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
Endoscope camera and light source integrated 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 | 697546580AGSHD2Q6 | 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 032a0372-c658-41f1-be46-0bc4578814b5 61 fields · synced Jun 18, 2026