Identity
- Trade Name
- ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit EUDAMED
- Device Name
- ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit EUDAMED
- Model / Reference
- K-4579 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800242990143 EUDAMED
- Basic UDI-DI
- 880024299K45793S 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
ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit by Bioneer Corporation — 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 | 880024299K45793S | Class A | Active |
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Manufacturer
- Manufacturer
- BIONEER Corporation
- EUDAMED SRN
- KR-MF-000018672
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d6898c2c-cfbe-4fe6-87f8-a09c0d0566de 61 fields · synced Jun 18, 2026