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Direct TIBC
EUDAMEDClass B (EU MDR)
Ref TIBC-0250Ref TIBC-6M30Model TIBC-M130Ref TIBC-5025Ref TIBC-6007
Identity
- Trade Name
- Direct TIBC EUDAMED
- Device Name
- Direct TIBC EUDAMED
- Model / Reference
- TIBC-0250 EUDAMEDTIBC-M130 EUDAMEDTIBC-6M30 EUDAMEDTIBC-5025 EUDAMEDTIBC-6007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700826408 EUDAMED03701700807629 EUDAMED03701700826415 EUDAMED03701700826422 EUDAMED
- Basic UDI-DI
- 37017008TIBC00A8 EUDAMED37017008TIBC01AA EUDAMED
- EMDN Code
- W01010217 IRON BINDING CAPACITY - TOTAL (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Direct TIBC by Vitalscientific — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008TIBC00A8 | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (4)
- EUDAMED 9514630a-8b3e-4d3a-889f-eaad664ccbae 61 fields · synced Jul 22, 2026
- EUDAMED 6ad5a00c-c1c6-4d4a-8434-a5dd9a8205ea 61 fields · synced May 17, 2026
- EUDAMED 40fd086a-0048-4e2e-86c8-e51215d4490b 61 fields · synced May 18, 2026
- EUDAMED cd08829c-7418-474a-b01c-815c39476965 61 fields · synced May 18, 2026