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SARS-CoV-2 Plus (N/ORF1ab/E/S 69_70del) RT-qPCR Reagent kit
EUDAMEDClass IVD General (EU MDR)
Ref 3515-0010
by Wallac Oy
Identity
- Trade Name
- SARS-CoV-2 Plus (N/ORF1ab/E/S 69_70del) RT-qPCR Reagent kit EUDAMED
- Device Name
- SARS-CoV-2 Plus (N/ORF1ab/E/S 69_70del) RT-qPCR Reagent kit EUDAMED
- Model / Reference
- 3515-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147383733 EUDAMED
- Basic UDI-DI
- B-06438147383733 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
SARS-CoV-2 Plus (N/ORF1ab/E/S 69_70del) RT-qPCR Reagent kit by Wallac Oy — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438147383733 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (1)
- EUDAMED c5d80074-67f7-478b-8a91-ee24770aa0fc 61 fields · synced Jul 22, 2026