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MagFast 16-Flex Genomic DNA Purification Kit From Blood
EUDAMEDClass A (EU MDR)
Ref MGF08Model MGF08P96Model MGF08P48
Identity
- Trade Name
- MagFast 16-Flex Genomic DNA Purification Kit From Blood EUDAMEDMagFast 16-Flex Genomic DNA Purification Kit From Blood EUDAMED
- Device Name
- 16-Flex Genomic DNA Purification Kit From Blood EUDAMED
- Model / Reference
- MGF08P96 EUDAMEDMGF08 EUDAMEDMGF08P48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595034538 EUDAMED08684595034521 EUDAMED
- Basic UDI-DI
- 868459503MGF08P963W EUDAMED868459503MGF08P483K EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 sample preparation instrument IVD
MagFast 16-Flex Genomic DNA Purification Kit From Blood by Vitrosens Biotechnology 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 | 868459503MGF08P963W | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED 8152abb9-91e7-4c74-b35a-8df10c13e68e 61 fields · synced Oct 6, 2026
- EUDAMED bfb6892c-ed0b-41d7-923c-fbe5d045f958 61 fields · synced May 17, 2026