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Automated Nucleic Acid Extraction System (Mole 96M)
EUDAMEDClass A (EU MDR)
Ref MLN96T101
Identity
- Device Name
- Automated Nucleic Acid Extraction System (Mole 96M) EUDAMED
- Model / Reference
- MLN96T101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895477567 EUDAMED
- Basic UDI-DI
- 697089547ANAE01NG EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece 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 (Mole 96M) by Jiangsu Mole Bioscience 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 | 697089547ANAE01NG | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b44806b7-2893-4129-b994-81f95be32bc9 61 fields · synced Jun 18, 2026