Identity
- Trade Name
- Endoscopic video processor EUDAMED
- Device Name
- Endoscopic video processor EUDAMED
- Model / Reference
- HDIS-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235409003 EUDAMED
- Basic UDI-DI
- 697423540HDISKG EUDAMED
- Direct Marketing DI
- 06974235409003 EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Iceland 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
Endoscopic video processor by Himaging Technology (Shanghai) 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 | 697423540HDISKG | Class I | Active |
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Manufacturer
- Manufacturer
- Himaging Technology (Shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000028002
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8d2e0615-e46b-45fd-a053-f260c92329ae 61 fields · synced Jul 15, 2026