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AutoMated Nucleic Acid Extraction System
EUDAMEDClass A (EU MDR)
Ref GeneX E6Model AutoMated Nucleic Acid Extraction SystemRef GeneX E6sModel GeneX E6, GeneX E6s
Identity
- Trade Name
- AutoMated Nucleic Acid Extraction System EUDAMED
- Device Name
- GeneX E6, GeneX E6s EUDAMEDAutoMated Nucleic Acid Extraction System EUDAMED
- Model / Reference
- AutoMated Nucleic Acid Extraction System EUDAMEDGeneX E6 EUDAMEDGeneX E6s EUDAMEDGeneX E6, GeneX E6s EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802605622 EUDAMED06926802605639 EUDAMED
- Basic UDI-DI
- 69268026GeneXE600000001P2 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
AutoMated Nucleic Acid Extraction System by Medcaptain Medical Technology 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 | 69268026GeneXE600000001P2 | Class A | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (4)
- EUDAMED 5e688b91-76cd-441e-be8f-78229f8bf555 61 fields · synced Jul 15, 2026
- EUDAMED ff1ccaf2-3497-4b67-b342-be234a3dcb33 61 fields · synced May 18, 2026
- EUDAMED f68755da-9530-4282-9149-0b28c127e21f 61 fields · synced Jun 19, 2026
- EUDAMED 38617c95-7464-4d6b-a9f9-0337543cc426 61 fields · synced Jul 15, 2026