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Neomass Aaac Plus
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 7100110Ref 7100100Ref 710011003
Identity
- Trade Name
- NEOMASS AAAC PLUS EUDAMEDNeoMass AAAC Plus dried blood spot (DBS) controls EUDAMED
- Device Name
- NEOMASS AAAC PLUS EUDAMEDNeoMass AAAC EUDAMEDNeoMass AAAC Plus DBS controls EUDAMED
- Model / Reference
- 7100110 EUDAMED7100100 EUDAMED710011003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438172403017 EUDAMED06438172400016 EUDAMED06438172403024 EUDAMED
- Basic UDI-DI
- B-06438172403017 EUDAMEDB-06438172400016 EUDAMEDB-06438172403024 EUDAMED
- EMDN Code
- W01010402 MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R. EUDAMEDW0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Neomass Aaac Plus by Labsystems Diagnostics Oy — Class IVD Annex II List B — 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-06438172403017 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (3)
- EUDAMED 7c7b6352-d8ce-4608-82cc-7c475e7df35d 61 fields · synced Jul 21, 2026
- EUDAMED b672becc-33c6-4ec0-9970-e5bd347e6eb2 61 fields · synced May 17, 2026
- EUDAMED 45edf2eb-70dd-49c7-8b78-b0c8270c5e6f 61 fields · synced May 18, 2026