Identity
- Trade Name
- BIOHIGH-GRADE EUDAMED
- Device Name
- Fully Automated Immunohistochemistry Staining Machine EUDAMED
- Model / Reference
- HGL-60V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16979511570009 EUDAMED
- Basic UDI-DI
- 697951157HA001FV EUDAMED
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Discover the fully automated immunohistochemistry staining machine from Beijing High-Grade Biotechnology Co., Ltd. This advanced device provides accurate and precise results for medical professionals, making it an ideal tool for diagnostic purposes.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697951157HA001FV | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing High-Grade Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000051358
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 9dce0458-9e4a-4e7f-a8da-f1d2f6a50205 61 fields · synced Jul 20, 2026