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EnLite Neonatal TREC kit
EUDAMEDClass IVD General (EU MDR)
Ref 3403-0010Ref 3402-0010
by Wallac Oy
Identity
- Trade Name
- EnLite Neonatal TREC kit EUDAMED
- Device Name
- EnLite Neonatal TREC kit EUDAMED
- Model / Reference
- 3403-0010 EUDAMED3402-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147331543 EUDAMED06438147331536 EUDAMED
- Basic UDI-DI
- B-06438147331543 EUDAMEDB-06438147331536 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
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
EnLite Neonatal TREC 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-06438147331543 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 0266f58d-af1f-4ff8-b621-a12d5ad09fff 61 fields · synced Jul 9, 2026
- EUDAMED f80f3bf0-fb50-4360-8ecf-8a1489586d50 61 fields · synced May 18, 2026