← Back to catalogue
NeoMass AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 710011004
Identity
- Trade Name
- NeoMass AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA) EUDAMED
- Device Name
- NeoMass AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA) EUDAMED
- Model / Reference
- 710011004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438172403031 EUDAMED
- Basic UDI-DI
- B-06438172403031 EUDAMED
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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 AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA) by Labsystems Diagnostics Oy — Class IVD Annex II List B — IVDD — listed in EUDAMED
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-06438172403031 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (1)
- EUDAMED 350a98bf-b641-45f1-b7a9-d67e30e41e05 61 fields · synced Jul 20, 2026