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HighPrep Viral DNA & RNA Kit - DX (3840 preps)
EUDAMEDClass A (EU MDR)
Ref HPV-DR3840EModel Kit for viral RNA and DNA isolation
Identity
- Trade Name
- HighPrep Viral DNA & RNA Kit - DX (3840 preps) EUDAMED
- Device Name
- HighPrep Viral DNA & RNA Kit - DX (3840 preps) EUDAMED
- Model / Reference
- Kit for viral RNA and DNA isolation EUDAMEDHPV-DR3840E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850045030995 EUDAMED
- Basic UDI-DI
- 0850045030HPV-DR3840ERV EUDAMED
- Direct Marketing DI
- 00850045030995 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
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 extraction/isolation kit IVD
HighPrep Viral DNA & RNA Kit - DX (3840 preps) by MagBio Genomics, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 0850045030HPV-DR3840ERV | Class A | Active |
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Manufacturer
- Manufacturer
- MagBio Genomics, Inc.
- EUDAMED SRN
- US-MF-000038221
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 2803f05e-7ae7-4713-b96b-f01ace61e8f4 61 fields · synced Jun 18, 2026