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4K UHD Camera System
EUDAMEDClass I (EU MDR)
Ref P4326EModel HK-S600,HK-S800,HK-162S,HK-162S,HK-162H,HK-162A
Identity
- Trade Name
- 4K UHD Camera System EUDAMED
- Device Name
- Camera System EUDAMED
- Model / Reference
- HK-S600,HK-S800,HK-162S,HK-162S,HK-162H,HK-162A EUDAMEDP4326E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014621149 EUDAMED
- Basic UDI-DI
- 69470146DQ00471010KM 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
- Austria 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
4K UHD Camera System by Hangzhou Hawk Optical Electronic Instruments 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 | 69470146DQ00471010KM | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2f48435d-84d9-456d-a790-7fb8c8cf3db4 61 fields · synced Jun 18, 2026