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IRON Kit
EUDAMEDClass IVD General (EU MDR)
Ref IRON KitModel IRON Kit 80mLRef B45307Model IRON Kit Ref B22210Model IRON Kit 180mL Ref B30211Model IRON Kit 140mLRef B21213Model Iron 216 mLRef B27210Model IRON Kit 420mL Ref B34210Model IRON Kit 183mLRef B21212Model Iron 70 mLRef B28211Model IRON Kit 156mLRef B29211Model IRON Kit 225mLRef B35211Model IRON Kit 90mLRef B33210
Identity
- Trade Name
- IRON Kit EUDAMEDIron EUDAMED
- Device Name
- IRON Kit EUDAMEDIron EUDAMED
- Model / Reference
- IRON Kit 80mL EUDAMEDIRON Kit EUDAMEDB45307 EUDAMEDIRON Kit 180mL EUDAMEDB22210 EUDAMEDIRON Kit 140mL EUDAMEDB30211 EUDAMEDIron 216 mL EUDAMEDB21213 EUDAMEDIRON Kit 420mL EUDAMEDB27210 EUDAMEDIRON Kit 183mL EUDAMEDB34210 EUDAMEDIron 70 mL EUDAMEDB21212 EUDAMEDIRON Kit 156mL EUDAMEDB28211 EUDAMEDIRON Kit 225mL EUDAMEDB29211 EUDAMEDIRON Kit 90mL EUDAMEDB35211 EUDAMEDB33210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555616029 EUDAMED08683555691149 EUDAMED08683555612151 EUDAMED08683555614445 EUDAMED08683555610706 EUDAMED08683555612939 EUDAMED08683555616753 EUDAMED08683555601070 EUDAMED08683555619044 EUDAMED08683555615152 EUDAMED08683555617477 EUDAMED08683555616012 EUDAMED
- Basic UDI-DI
- B-08683555616029 EUDAMEDB-08683555691149 EUDAMEDB-08683555612151 EUDAMEDB-08683555614445 EUDAMEDB-08683555610706 EUDAMEDB-08683555612939 EUDAMEDB-08683555616753 EUDAMEDB-08683555601070 EUDAMEDB-08683555619044 EUDAMEDB-08683555615152 EUDAMEDB-08683555617477 EUDAMEDB-08683555616012 EUDAMED
- EMDN Code
- W01010216 IRON (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
IRON Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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-08683555616029 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (12)
- EUDAMED 3c03357c-5c74-44f8-af72-9460565fc6d4 61 fields · synced Oct 5, 2026
- EUDAMED 7bc5e9e6-b71f-42f1-8c1b-85c58257be06 61 fields · synced May 16, 2026
- EUDAMED 960b6093-5c77-4d78-939c-46ee435acac2 61 fields · synced May 17, 2026
- EUDAMED bb8d106e-e52c-4f00-8c50-3874a2a59db2 61 fields · synced May 17, 2026
- EUDAMED 0d38e33d-0e9c-41d5-b019-02da0f9d4afa 61 fields · synced May 17, 2026
- EUDAMED 229e3879-8c8d-404d-ac35-5c47ca4685de 61 fields · synced May 17, 2026
- EUDAMED 90a4d0cb-fdb3-4cfb-b234-a500c88c9281 61 fields · synced May 17, 2026
- EUDAMED 48fdeadc-9822-4dd7-9424-82754e6b31b3 61 fields · synced May 17, 2026
- EUDAMED 741902e0-e25d-49eb-9511-40ad83d7786f 61 fields · synced May 17, 2026
- EUDAMED e72d4d6d-13b2-4b09-93c7-9b729cee851e 61 fields · synced May 18, 2026
- EUDAMED a2338786-bf43-4616-a496-071a3e9d91e7 61 fields · synced May 18, 2026
- EUDAMED f7f3d0a9-53ba-4072-acd1-7cebf340ae38 61 fields · synced May 19, 2026