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IMMUNOGLOBULIN G (IgG)
EUDAMEDClass IVD General (EU MDR)
Ref 31076Ref 13081Ref 31070Ref 31081
Identity
- Device Name
- IMMUNOGLOBULIN G (IgG) EUDAMED
- Model / Reference
- 31076 EUDAMED13081 EUDAMED31070 EUDAMED31081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287110760 EUDAMED08435287130812 EUDAMED08435287110708 EUDAMED08435287110814 EUDAMED
- Basic UDI-DI
- B-08435287110760 EUDAMEDB-08435287130812 EUDAMEDB-08435287110708 EUDAMEDB-08435287110814 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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 (IgG) by Biosystems S.a. — Class IVD General — IVDD — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08435287110760 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED a1cde03e-cf5e-44d4-b393-4139e19b0b8c 61 fields · synced Jul 28, 2026
- EUDAMED e219f953-c667-481d-bfd6-3988f45c1c61 61 fields · synced May 16, 2026
- EUDAMED 60a6b871-a5e3-4239-8fc3-7fed2a5fb645 61 fields · synced May 16, 2026
- EUDAMED 010a2fdd-747f-4063-af1b-a52ed4b8a1b0 61 fields · synced May 17, 2026