Identity
- Trade Name
- Nucleic Acid Extractor System EUDAMED
- Device Name
- Nucleic Acid Extractor System EUDAMED
- Model / Reference
- MultiEx 032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973698770361 EUDAMED
- Basic UDI-DI
- 697369877MultiEx032RW EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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
Nucleic Acid Extractor System by Guangzhou Four E’s Healthcare 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 | 697369877MultiEx032RW | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Four E’s Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000023274
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 6ab5eace-0839-4a68-8123-41b591e19132 61 fields · synced Jun 20, 2026