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Automatic Nucleic Acid Extractor
EUDAMEDClass A (EU MDR)
Ref A03010017Model L-20Ref A03010010Model A-32
Identity
- Device Name
- Automatic Nucleic Acid Extractor EUDAMED
- Model / Reference
- L-20 EUDAMEDA03010017 EUDAMEDA-32 EUDAMEDA03010010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500293 EUDAMED06937044500262 EUDAMED
- Basic UDI-DI
- 069370445anucaA03010004XS EUDAMED069370445anucaA03010001XL EUDAMED
- Direct Marketing DI
- 06937044500293 EUDAMED06937044500262 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
Category: Nucleic acid sample preparation instrument IVD
Automatic Nucleic Acid Extractor by Ningbo HEALTH Gene Technologies Co., LTD. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid sample preparation instrument IVD.
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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 | 069370445anucaA03010004XS | Class A | Active |
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Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED fdd68e8a-cd49-4040-85f9-38aec704db72 61 fields · synced Aug 2, 2026
- EUDAMED e0923199-30c0-4e61-940d-6a96ca87d9bd 61 fields · synced May 17, 2026