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TANBead Nucleic Acid Extraction Kit
EUDAMEDClass A (EU MDR)
Ref W66PS66-MSModel 66P-MS series
Identity
- Device Name
- TANBead Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- 66P-MS series EUDAMEDW66PS66-MS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880124244 EUDAMED
- Basic UDI-DI
- 47198801266PJC 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 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
TANBead Nucleic Acid Extraction Kit by Taiwan Advanced Nanotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 47198801266PJC | 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 94a1f449-deab-47e0-8ad2-134b831c0da0 61 fields · synced Jun 20, 2026