Identity
- Trade Name
- Respiratory Multiplex RT-PCR Kit EUDAMED
- Device Name
- Respiratory Multiplex RT-PCR Kit EUDAMED
- Model / Reference
- 8100532 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438172315013 EUDAMED
- Basic UDI-DI
- B-06438172315013 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
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Respiratory Multiplex RT-PCR Kit by Labsystems Diagnostics 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-06438172315013 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (1)
- EUDAMED a30628f0-d587-4846-9df0-e71237680c56 61 fields · synced Jun 17, 2026