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NeoNat SCID-SMA Real-Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref 8100481Ref 8100483Ref 8100482
Identity
- Trade Name
- NeoNat SCID-SMA Real-Time PCR Kit EUDAMED
- Device Name
- NeoNat SCID-SMA Real-Time PCR Kit EUDAMED
- Model / Reference
- 8100481 EUDAMED8100483 EUDAMED8100482 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438172311015 EUDAMED06438172311039 EUDAMED06438172311022 EUDAMED
- Basic UDI-DI
- B-06438172311015 EUDAMEDB-06438172311039 EUDAMEDB-06438172311022 EUDAMED
- EMDN Code
- W0106010299 POLYGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
NeoNat SCID-SMA Real-Time 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-06438172311015 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (3)
- EUDAMED 57d25491-40ce-4298-a224-8f97aa2e33bd 61 fields · synced Aug 2, 2026
- EUDAMED 397523a4-6484-4bd3-8988-2fa715e8621d 61 fields · synced May 17, 2026
- EUDAMED d5b7697c-9e37-47cc-8303-b7af58b2b21b 61 fields · synced May 18, 2026