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Glomerular Basement Membrane Antibodies (gbma)
EUDAMEDClass IVD General (EU MDR)
Ref 55567Ref 44588
Identity
- Device Name
- GLOMERULAR BASEMENT MEMBRANE ANTIBODIES (GBMA) EUDAMED
- Model / Reference
- 55567 EUDAMED44588 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08012992555675 EUDAMED08435287144888 EUDAMED
- Basic UDI-DI
- B-08012992555675 EUDAMEDB-08435287144888 EUDAMED
- EMDN Code
- W0102109014 ANTIBODIES TO GLOMERULAR BASAL MEMBRANE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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
Glomerular Basement Membrane Antibodies (gbma) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08012992555675 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 7246d3af-df8e-4a41-9d3b-cedca26372b3 61 fields · synced Jul 18, 2026
- EUDAMED 8bf6f19b-3460-4d77-9a91-01f53a52c792 61 fields · synced May 18, 2026