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Automatic Nucleic Acid Extraction System
EUDAMEDClass A (EU MDR)
Ref EGN9101005Model N 32，N 96Ref EGN9101006
Identity
- Trade Name
- Automatic Nucleic Acid Extraction System EUDAMED
- Device Name
- Automatic Nucleic Acid Extraction System EUDAMED
- Model / Reference
- N 32，N 96 EUDAMEDEGN9101005 EUDAMEDEGN9101006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168350782 EUDAMED06972168350775 EUDAMED
- Basic UDI-DI
- 6972168353003A4 EUDAMED
- Direct Marketing DI
- 06972168350782 EUDAMED06972168350775 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Automatic Nucleic Acid Extraction System by Maccura Medical Instrument 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 | 6972168353003A4 | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED c8925f31-ba7c-4177-8fc8-28f492ee49e2 61 fields · synced Aug 1, 2026
- EUDAMED dc6de739-85f5-4651-b9be-763d8752ccba 61 fields · synced May 18, 2026