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Portable Nucleic Acid Detection Instrument
EUDAMEDClass A (EU MDR)
Ref MAtriX-Mini
Identity
- Trade Name
- Portable Nucleic Acid Detection Instrument EUDAMED
- Device Name
- Portable Nucleic Acid Detection Instrument EUDAMED
- Model / Reference
- MAtriX-Mini EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975275770146 EUDAMED
- Basic UDI-DI
- 697527577004P3 EUDAMED
- Direct Marketing DI
- 06975275770146 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Portable Nucleic Acid Detection Instrument by Suzhou Molarray 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 | 697527577004P3 | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou Molarray Co., Ltd
- EUDAMED SRN
- CN-MF-000053786
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 3b2fd6aa-4872-4604-b73b-7846a267f600 61 fields · synced Jun 18, 2026