Identity
- Trade Name
- Immunoglobulin G EUDAMED
- Device Name
- Immunoglobulin G EUDAMED
- Model / Reference
- 981937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153819377 EUDAMED
- Basic UDI-DI
- 6438153BU00109BQ EUDAMEDB-16438153819377 EUDAMED
- Direct Marketing DI
- 16438153819377 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass 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
New Device
No
EUDAMED
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Immunoglobulin G by Thermo Fisher Scientific Oy — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6438153BU00109BQ | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00109BQ | Class B | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED 0a2b72e3-c3db-4902-a237-0f1d4f700fd6 61 fields · synced Oct 6, 2026
- EUDAMED dd0a1e9d-430e-4a21-ad8f-06ca59c61ad2 61 fields · synced May 17, 2026