Identity
- Trade Name
- Prime DNA/RNA Extraction kit EUDAMED
- Device Name
- Prime DNA/RNA Extraction kit EUDAMED
- Model / Reference
- 80-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251557109098 EUDAMED
- Basic UDI-DI
- 42515571PRIMEDNA37 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
Prime DNA/RNA Extraction kit by Astra Biotech GmbH — 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 | 42515571PRIMEDNA37 | Class A | Active |
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Manufacturer
- Manufacturer
- Astra Biotech GmbH
- EUDAMED SRN
- DE-MF-000026439
Sources (1)
- EUDAMED 42efe49d-00b9-4800-b9e7-7a0884d815c4 61 fields · synced Jul 9, 2026