Identity
- Trade Name
- Galaxy Neo EUDAMED
- Device Name
- Automated Fully Enclosed qPCR Instrument EUDAMED
- Model / Reference
- Galaxy EUDAMED101-0062-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975447581068 EUDAMED
- Basic UDI-DI
- 697544758GALAXYU9 EUDAMED
- Direct Marketing DI
- 06975447581068 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Category: Nucleic acid sample preparation instrument IVD
Galaxy Neo by Igenesis(Shanghai)Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697544758GALAXYU9 | Class A | Active |
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Manufacturer
- Manufacturer
- Igenesis(Shanghai)Co., Ltd.
- EUDAMED SRN
- CN-MF-000001552
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 58f8584e-7e2d-4974-9f3f-f2f174c3a598 61 fields · synced Jun 18, 2026