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TANBead Nucleic Acid Extraction Kit
EUDAMEDClass A (EU MDR)
Ref 612S46Model 612 seriesRef M635A46Model 635 seriesRef S91CA24Model 61C seriesRef W611S66Model 611 seriesRef M612S46Ref M61FA46Model 61F seriesRef M621A46Model 621 seriesRef W611A46Ref W612S66Ref W612A46Ref W63FA46Model 63F seriesRef M615A46Model 615 seriesRef M61CS24-KE1Ref W63FS66Ref M611A46Ref 612A46Ref M61ES46-NXModel 61E seriesRef 615A46Ref W615S66Ref W635S66Ref W615A46Ref W621A46Ref M61E046-NXRef S91C045Ref W66PA46-MSModel 66P-MS seriesRef M621S46Ref 615S46Ref 6TFA46Model 6TF seriesRef W6TFS66Ref W621S66Ref M63FS46Ref 635S46Ref 611A46Ref W61GA46-SEModel 61G seriesRef 61FS46Ref W61EA46-NXRef M612A46Ref M61EA46-NXRef W635A46Ref 61ES46-NXRef M63FA46Ref 6TFS46
Identity
- Device Name
- TANBead Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- 612 series EUDAMED612S46 EUDAMED635 series EUDAMEDM635A46 EUDAMED61C series EUDAMEDS91CA24 EUDAMED611 series EUDAMEDW611S66 EUDAMEDM612S46 EUDAMED61F series EUDAMEDM61FA46 EUDAMED621 series EUDAMEDM621A46 EUDAMEDW611A46 EUDAMEDW612S66 EUDAMEDW612A46 EUDAMED63F series EUDAMEDW63FA46 EUDAMED615 series EUDAMEDM615A46 EUDAMEDM61CS24-KE1 EUDAMEDW63FS66 EUDAMEDM611A46 EUDAMED612A46 EUDAMED61E series EUDAMEDM61ES46-NX EUDAMED615A46 EUDAMEDW615S66 EUDAMEDW635S66 EUDAMEDW615A46 EUDAMEDW621A46 EUDAMEDM61E046-NX EUDAMEDS91C045 EUDAMED66P-MS series EUDAMEDW66PA46-MS EUDAMEDM621S46 EUDAMED615S46 EUDAMED6TF series EUDAMED6TFA46 EUDAMEDW6TFS66 EUDAMEDW621S66 EUDAMEDM63FS46 EUDAMED635S46 EUDAMED611A46 EUDAMED61G series EUDAMEDW61GA46-SE EUDAMED61FS46 EUDAMEDW61EA46-NX EUDAMEDM612A46 EUDAMEDM61EA46-NX EUDAMEDW635A46 EUDAMED61ES46-NX EUDAMEDM63FA46 EUDAMED6TFS46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880121533 EUDAMED04719880122158 EUDAMED04719880124121 EUDAMED04719880122271 EUDAMED04719880122028 EUDAMED04719880122196 EUDAMED04719880122615 EUDAMED04719880122264 EUDAMED04719880122318 EUDAMED04719880122301 EUDAMED04719880124190 EUDAMED04719880122097 EUDAMED04719880122776 EUDAMED04719880124206 EUDAMED04719880121977 EUDAMED04719880121526 EUDAMED04719880123919 EUDAMED04719880121441 EUDAMED04719880122387 EUDAMED04719880122707 EUDAMED04719880122370 EUDAMED04719880122868 EUDAMED04719880123940 EUDAMED04719880124145 EUDAMED04719880124237 EUDAMED04719880122622 EUDAMED04719880121458 EUDAMED04719880122882 EUDAMED04719880122660 EUDAMED04719880122875 EUDAMED04719880124183 EUDAMED04719880121403 EUDAMED04719880121366 EUDAMED04719880122981 EUDAMED04719880121618 EUDAMED04719880123926 EUDAMED04719880122011 EUDAMED04719880123902 EUDAMED04719880122431 EUDAMED04719880123896 EUDAMED04719880124176 EUDAMED04719880122899 EUDAMED
- Basic UDI-DI
- 471988012612G3 EUDAMED471988012635GF EUDAMED47198801261CH3 EUDAMED471988012611FZ EUDAMED47198801261FH9 EUDAMED471988012621G4 EUDAMED47198801263FHF EUDAMED471988012615G9 EUDAMED47198801261EH7 EUDAMED47198801266PJC EUDAMED4719880126TFLF EUDAMED47198801261GHB EUDAMED
- Direct Marketing DI
- 04719880121533 EUDAMED04719880122158 EUDAMED04719880122271 EUDAMED04719880122028 EUDAMED04719880122196 EUDAMED04719880122615 EUDAMED04719880122264 EUDAMED04719880122318 EUDAMED04719880122301 EUDAMED04719880122097 EUDAMED04719880122776 EUDAMED04719880121977 EUDAMED04719880121526 EUDAMED04719880121441 EUDAMED04719880122387 EUDAMED04719880122707 EUDAMED04719880122370 EUDAMED04719880122868 EUDAMED04719880122622 EUDAMED04719880121458 EUDAMED04719880122882 EUDAMED04719880122660 EUDAMED04719880122875 EUDAMED04719880121403 EUDAMED04719880121366 EUDAMED04719880122981 EUDAMED04719880121618 EUDAMED04719880122011 EUDAMED04719880122431 EUDAMED04719880122899 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Category: Nucleic acid extraction/isolation kit IVD
TANBead Nucleic Acid Extraction Kit 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 | 471988012612G3 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Taiwan Advanced Nanotech Inc.
- EUDAMED SRN
- TW-MF-000019040
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (42)
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- EUDAMED 3638ee7f-3b1c-43fe-b222-0595b3029be7 61 fields · synced May 18, 2026
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- EUDAMED ea031578-606f-4bb6-9144-db818d15e014 61 fields · synced May 19, 2026
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