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TANBead Nucleic Acid Extractor
EUDAMEDClass A (EU MDR)
Ref Maelstrom 2410 (220V)Model Maelstrom 2410Ref Maelstrom 8 Autostage (220V)Model Maelstrom 8 AutostageRef Maelstrom 9610 LHRef Maelstrom 9610 (220V)Model Maelstrom 9610Ref Maelstrom 9600 (220V)Model Maelstrom 9600
Identity
- Device Name
- TANBead Nucleic Acid Extractor EUDAMED
- Model / Reference
- Maelstrom 2410 EUDAMEDMaelstrom 2410 (220V) EUDAMEDMaelstrom 8 Autostage EUDAMEDMaelstrom 8 Autostage (220V) EUDAMEDMaelstrom 9610 LH EUDAMEDMaelstrom 9610 EUDAMEDMaelstrom 9610 (220V) EUDAMEDMaelstrom 9600 EUDAMEDMaelstrom 9600 (220V) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880128884 EUDAMED04719880129249 EUDAMED04719880128822 EUDAMED04719880129454 EUDAMED04719880129515 EUDAMED
- Basic UDI-DI
- 471988012M24105Z EUDAMED471988012S04LG EUDAMED471988012M96LHBQ EUDAMED471988012M96107U EUDAMED471988012M96007R EUDAMED
- Direct Marketing DI
- 04719880128884 EUDAMED04719880129249 EUDAMED04719880128822 EUDAMED04719880129454 EUDAMED04719880129515 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMEDSweden 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 | 471988012M24105Z | 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 (5)
- EUDAMED a60a1b62-6b6c-47de-a833-1f6ebcb43bf0 61 fields · synced Aug 3, 2026
- EUDAMED 92983189-8389-495c-8286-3fba75a3be72 61 fields · synced May 17, 2026
- EUDAMED 916a8cfc-3369-4f8c-a4a9-72491b009fdf 61 fields · synced May 18, 2026
- EUDAMED 5fa23662-4801-4e1b-a42a-0e59f5c2ad05 61 fields · synced May 18, 2026
- EUDAMED 0bfc1f9e-1808-49a8-83ff-9411d36ce103 61 fields · synced May 18, 2026