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TANBead Nucleic Acid Extractor
EUDAMEDClass A (EU MDR)
Ref Maelstrom Switch 8Model Maelstrom 8 Autostage
Identity
- Device Name
- TANBead Nucleic Acid Extractor EUDAMED
- Model / Reference
- Maelstrom 8 Autostage EUDAMEDMaelstrom Switch 8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880128600 EUDAMED
- Basic UDI-DI
- 471988012S04LG EUDAMED
- Direct Marketing DI
- 04719880128600 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
TANBead Nucleic Acid Extractor by Taiwan Advanced Nanotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471988012S04LG | Class A | Active |
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Manufacturer
- Manufacturer
- Taiwan Advanced Nanotech Inc.
- EUDAMED SRN
- TW-MF-000019040
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 9bd27acd-a5e0-4825-81c5-3a75b6c458a3 61 fields · synced Jun 20, 2026