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NeoMass CAH System Suitability Mixture (lyophilized)
EUDAMEDClass IVD General (EU MDR)
Ref 3467709
Identity
- Trade Name
- NeoMass CAH System Suitability Mixture (lyophilized) EUDAMED
- Device Name
- NeoMass CAH System Suitability Mixture (lyophilized) EUDAMED
- Model / Reference
- 3467709 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438172401129 EUDAMED
- Basic UDI-DI
- B-06438172401129 EUDAMED
- EMDN Code
- W0102152202 HORMONE STANDARDS AND CALIBRATORS 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
NeoMass CAH System Suitability Mixture (lyophilized) 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-06438172401129 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (1)
- EUDAMED 872d1eee-df87-4d6e-b5a5-9df3a7c16d16 61 fields · synced Jun 18, 2026