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IMMUNOGLOBULIN M (IgM)
EUDAMEDClass IVD General (EU MDR)
Ref 31083Ref 13083Ref 31072Ref 31078
Identity
- Device Name
- IMMUNOGLOBULIN M (IgM) EUDAMED
- Model / Reference
- 31083 EUDAMED13083 EUDAMED31072 EUDAMED31078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287110838 EUDAMED08435287130836 EUDAMED08435287110722 EUDAMED08435287130782 EUDAMED
- Basic UDI-DI
- B-08435287110838 EUDAMEDB-08435287130836 EUDAMEDB-08435287110722 EUDAMEDB-08435287130782 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M 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
IMMUNOGLOBULIN M (IgM) 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-08435287110838 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED d9cf30c7-8554-4f9a-a292-fabd5aceab5f 61 fields · synced Jul 20, 2026
- EUDAMED e7a32263-112d-4728-823a-f5bc8fe6b43a 61 fields · synced May 18, 2026
- EUDAMED 8b0b1568-fdeb-412a-9f79-ebd88c441768 61 fields · synced May 18, 2026
- EUDAMED dcd433fe-6b5d-4025-80d0-203050c4b5ff 61 fields · synced May 19, 2026