Identity
- Trade Name
- Genomate EUDAMED
- Device Name
- Genomate workstation EUDAMED
- Model / Reference
- 0100101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979343850020 EUDAMED
- Basic UDI-DI
- 697934385010016Z EUDAMED
- Direct Marketing DI
- 06979343850020 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Genomate by Genecast (Wuhan) Precision Diagnostic Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697934385010016Z | Class A | Active |
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Manufacturer
- Manufacturer
- Genecast (Wuhan) Precision Diagnostic Co., Ltd.
- EUDAMED SRN
- CN-MF-000051330
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 1c6c3d40-c73e-4373-861c-584215df848e 61 fields · synced Jul 13, 2026