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Transferrin
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref 13091Ref 31092Ref 31093
Identity
- Device Name
- TRANSFERRIN EUDAMED
- Model / Reference
- 13091 EUDAMED31092 EUDAMED31093 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287130911 EUDAMED08435287110920 EUDAMED08435287110937 EUDAMED
- Basic UDI-DI
- B-08435287130911 EUDAMEDB-08435287110920 EUDAMEDB-08435287110937 EUDAMED
- EMDN Code
- W0102010307 TRANSFERRIN 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
Transferrin by Biosystems S.a. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190495 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08435287130911 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED af582928-f8b3-4217-a16f-5527b654269e 61 fields · synced Jul 18, 2026
- EUDAMED c09a3813-bc37-4d41-a273-f84e9fc0140e 61 fields · synced May 17, 2026
- EUDAMED 380a76ec-5935-4e41-b627-7ffa0e59dabd 61 fields · synced May 18, 2026
- FDA 510(k) K190495 1 fields · synced May 18, 2026