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Nucleic Acid Extractor
EUDAMEDClass A (EU MDR)
Ref MultiEX 024L，MultiEX 016，MultiEX 096P
Identity
- Device Name
- Nucleic Acid Extractor EUDAMED
- Model / Reference
- MultiEX 024L，MultiEX 016，MultiEX 096P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977426530005 EUDAMED
- Basic UDI-DI
- 6977426530015D2 EUDAMED
- Direct Marketing DI
- 06977426530005 EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Nucleic Acid Extractor by Guangzhou Four E’s Scientific 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 | 6977426530015D2 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Four E’s Scientific Co., Ltd
- EUDAMED SRN
- CN-MF-000043042
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 3b5fb0d3-5808-4ecd-ae12-c1917f9c4235 61 fields · synced Jul 13, 2026