← Back to catalogue
Total Iron-Binding Capacity Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref TIBC6011Y, TIBC6012Y, TIBC6013Y, TIBC6014Y, TIBC6015Y, TIBC6011N, TIBC6012N, TIBC6013N, TIBC6014N, TIBC6015N
Identity
- Trade Name
- Total Iron-Binding Capacity Reagent Kit EUDAMED
- Device Name
- Total Iron-Binding Capacity Reagent Kit EUDAMED
- Model / Reference
- TIBC6011Y, TIBC6012Y, TIBC6013Y, TIBC6014Y, TIBC6015Y, TIBC6011N, TIBC6012N, TIBC6013N, TIBC6014N, TIBC6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TIBC601YT EUDAMED
- Basic UDI-DI
- B-TIBC601YT EUDAMED
- EMDN Code
- W01010217 IRON BINDING CAPACITY - TOTAL (CC) 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
Total Iron-Binding Capacity Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-TIBC601YT | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED f4d828ac-8d97-48b4-b618-1de71060016b-1 61 fields · synced Jul 8, 2026
- EUDAMED f4d828ac-8d97-48b4-b618-1de71060016b-2 61 fields · synced Jun 18, 2026