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TANBead Nucleic Acid Extraction Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref M6T2046Model 6T2 series
Identity
- Trade Name
- TANBead Nucleic Acid Extraction Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- TANBead Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- 6T2 series EUDAMEDM6T2046 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719880122721 EUDAMEDFDA UDI
- Basic UDI-DI
- 4719880126T2K9 EUDAMED
- Direct Marketing DI
- 04719880122721 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
TANBead Nucleic Acid Extraction Kit by Taiwan Advanced Nanotech Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4719880126T2K9 | 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 19d23def-14fb-49ff-aafe-9cad3f43c973 61 fields · synced Jul 11, 2026
- FDA UDI b00955b2-4383-4579-b618-624e91b5e40b 33 fields · synced May 30, 2026