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MagFast 16-Flex Total Nucleic Acid Purification Kit
EUDAMEDClass A (EU MDR)
Ref MGF04Model MGF04P96Model MGF04P48
Identity
- Trade Name
- MagFast 16-Flex Total Nucleic Acid Purification Kit EUDAMED
- Device Name
- 16-Flex Total Nucleic Acid Purification Kit EUDAMED
- Model / Reference
- MGF04P96 EUDAMEDMGF04 EUDAMEDMGF04P48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595032220 EUDAMED08684595034422 EUDAMED
- Basic UDI-DI
- 868459503MGF04P9632 EUDAMED868459503MGF04P482P 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
MagFast 16-Flex Total Nucleic Acid Purification Kit by Vitrosens Biotechnology 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 | 868459503MGF04P9632 | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED a2449f37-0b5e-4fd0-a489-ec6d4f4ece44 61 fields · synced Oct 6, 2026
- EUDAMED e40c5264-f495-4996-ab0a-34cf3f91c77f 61 fields · synced May 17, 2026