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BILIRUBIN DIRECT Kit
EUDAMEDClass IVD General (EU MDR)
Ref B33056Model BILIRUBIN DIRECT Kit 210mLRef B33055Model BILIRUBIN DIRECT Kit 420mLRef B45055Model BILIRUBIN DIRECT KitRef B45056Ref B28055Model BILIRUBIN DIRECT Kit 312mL Ref B34056Model BILIRUBIN DIRECT Kit 122mLRef B24055Model BILIRUBIN DIRECT Kit 170mL Ref B29056Model BILIRUBIN DIRECT Kit 225mLRef B30055Ref B27056Model BILIRUBIN DIRECT Kit 234mLRef B30056Ref B29055Model BILIRUBIN DIRECT Kit 105mL
Identity
- Trade Name
- BILIRUBIN DIRECT Kit EUDAMED
- Device Name
- BILIRUBIN DIRECT Kit EUDAMED
- Model / Reference
- BILIRUBIN DIRECT Kit 210mL EUDAMEDB33056 EUDAMEDBILIRUBIN DIRECT Kit 420mL EUDAMEDB33055 EUDAMEDBILIRUBIN DIRECT Kit EUDAMEDB45055 EUDAMEDB45056 EUDAMEDBILIRUBIN DIRECT Kit 312mL EUDAMEDB28055 EUDAMEDBILIRUBIN DIRECT Kit 122mL EUDAMEDB34056 EUDAMEDBILIRUBIN DIRECT Kit 170mL EUDAMEDB24055 EUDAMEDBILIRUBIN DIRECT Kit 225mL EUDAMEDB29056 EUDAMEDB30055 EUDAMEDBILIRUBIN DIRECT Kit 234mL EUDAMEDB27056 EUDAMEDB30056 EUDAMEDBILIRUBIN DIRECT Kit 105mL EUDAMEDB29055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555615602 EUDAMED08683555601568 EUDAMED08683555622211 EUDAMED08683555622228 EUDAMED08683555618573 EUDAMED08683555616449 EUDAMED08683555613387 EUDAMED08683555614858 EUDAMED08683555614025 EUDAMED08683555612489 EUDAMED08683555614032 EUDAMED08683555614841 EUDAMED
- Basic UDI-DI
- B-08683555615602 EUDAMEDB-08683555601568 EUDAMEDB-08683555622211 EUDAMEDB-08683555622228 EUDAMEDB-08683555618573 EUDAMEDB-08683555616449 EUDAMEDB-08683555613387 EUDAMEDB-08683555614858 EUDAMEDB-08683555614025 EUDAMEDB-08683555612489 EUDAMEDB-08683555614032 EUDAMEDB-08683555614841 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN 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
BILIRUBIN DIRECT 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-08683555615602 | 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 95addbf4-fa73-488c-b062-21e2c6a14b2b 61 fields · synced Oct 6, 2026
- EUDAMED de0c441c-8314-46a8-b1f0-42a90509de01 61 fields · synced May 16, 2026
- EUDAMED 6cbb63f4-ab3f-4ac3-a5ed-d93507fb2523 61 fields · synced May 17, 2026
- EUDAMED fd013721-49d4-4fb5-8772-6e038c4697a0 61 fields · synced May 17, 2026
- EUDAMED 44896579-12e2-40f7-adac-b48afb4fed0c 61 fields · synced May 18, 2026
- EUDAMED 457ab98c-19cf-481c-b863-2282a8977ed5 61 fields · synced May 18, 2026
- EUDAMED 09006588-8f92-485d-8680-aae92b99d48e 61 fields · synced May 18, 2026
- EUDAMED 01d87c5b-9777-4555-97a0-5a717b4c47f5 61 fields · synced May 18, 2026
- EUDAMED 6587ef57-a533-49f2-87c4-d7c88301f5ac 61 fields · synced May 18, 2026
- EUDAMED 9b51dfc4-2336-4509-8104-0abc6f2747b4 61 fields · synced May 19, 2026
- EUDAMED c68d8fec-df14-43cf-9769-3c385643aa40 61 fields · synced May 19, 2026
- EUDAMED 1662b557-b21f-4473-b87a-1b512e9823b3 61 fields · synced May 19, 2026