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IgG FITC

EUDAMED

Class IVD General (EU MDR)

Ref 44838Ref 56252Ref 50380Ref 50379Ref 12012272

by Biosystems S.a.

Identity

Device Name
IgG FITC EUDAMED
IgG FITC/EVANS (M) EUDAMED
IgG FITC/EVANS EUDAMED
IgG FITC/EVANS (M) hs EUDAMED
Model / Reference
44838 EUDAMED
56252 EUDAMED
50380 EUDAMED
50379 EUDAMED
12012272 EUDAMED

Identifiers

Primary DI / UDI-DI
08435287104318 EUDAMED
08012992562529 EUDAMED
08012992503805 EUDAMED
08012992503799 EUDAMED
03610522158256 EUDAMED
Basic UDI-DI
B-08435287104318 EUDAMED
B-08012992562529 EUDAMED
B-08012992503805 EUDAMED
B-08012992503799 EUDAMED
B-03610522158256 EUDAMED
EMDN Code
W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMEDEUDAMED

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

New Device

No

EUDAMED

IgG FITC by Biosystems S.a. — 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

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Manufacturer

Manufacturer
Biosystems S.a.
EUDAMED SRN
ES-MF-000000231

Sources (5)

  • EUDAMED 07112a1e-769c-4ec4-ba10-5f818b0606c5 61 fields · synced Jul 31, 2026
  • EUDAMED 6202e523-0197-45f2-a173-69e468177bde 61 fields · synced May 17, 2026
  • EUDAMED b05eda2f-bf30-410a-9b6c-31f3089dfae8 61 fields · synced May 17, 2026
  • EUDAMED ac160df0-5cbb-42f0-95e6-45ebdd68ab4c 61 fields · synced May 19, 2026
  • EUDAMED 61d51d54-ce95-4678-81a3-1b59470b51e8 61 fields · synced May 19, 2026