TANBead Nucleic Acid Extractor
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- TANBead Nucleic Acid Extractor FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- TANBead Nucleic Acid Extractor EUDAMED
- Model / Reference
- Maelstrom 9600 EUDAMEDFDA UDIMaelstrom 9600 (110V) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880129485 EUDAMEDFDA UDI
- Basic UDI-DI
- 471988012M96007R EUDAMED
- Direct Marketing DI
- 04719880129485 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Nucleic acid sample preparation instrument IVD
TANBead Nucleic Acid Extractor by Taiwan Advanced Nanotech Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 471988012M96007R | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Taiwan Advanced Nanotech Inc.
- EUDAMED SRN
- TW-MF-000019040
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 0ae49f6b-ec7f-4b88-b03e-12e57bd807d0 61 fields · synced Jun 20, 2026
- FDA UDI b5e1b56f-4040-48ea-b09f-242020beaca1 32 fields · synced May 30, 2026