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NeoNat SMA Real-Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref 8100462Ref 8100463
Identity
- Trade Name
- NeoNat SMA Real-Time PCR Kit EUDAMED
- Device Name
- NeoNat SMA Real-Time PCR Kit EUDAMED
- Model / Reference
- 8100462 EUDAMED8100463 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438172310025 EUDAMED06438172310032 EUDAMED
- Basic UDI-DI
- B-06438172310025 EUDAMEDB-06438172310032 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 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-06438172310025 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (2)
- EUDAMED b1faccb6-996d-4f76-90cb-c7e74cede79e 61 fields · synced Jul 12, 2026
- EUDAMED 679aabdd-3e49-4572-bbcd-b36a8205fcfd 61 fields · synced May 18, 2026