Identity
- Trade Name
- Express Genetics DNA EUDAMED
- Device Name
- Express Genetics DNA EUDAMED
- Model / Reference
- 0018 EUDAMEDLVE-0018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04751042630057 EUDAMED
- Basic UDI-DI
- 4751042630057VS 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
- Latvia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Yes
EUDAMED
Express Genetics DNA by SIA Laboveritas — 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 | 4751042630057VS | Class A | Active |
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Manufacturer
- Manufacturer
- SIA Laboveritas
- EUDAMED SRN
- LV-MF-000018225
Sources (1)
- EUDAMED 53a16c11-6928-4a9d-93ad-9bb6b4f57c73 61 fields · synced Jun 18, 2026