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UREA-S Kit
EUDAMEDClass IVD General (EU MDR)
Ref B21488Model UREA-S KitRef B33291Model UREA-S Kit 210mLRef B29290Model UREA-S Kit 300mLRef B34291Model UREA-S Kit 244mLRef B35291Model UREA-S Kit 290mLRef B21292Model UREA-S Kit 204mLRef B45291Model UREA-S Kit Ref B27290SRef B30290Model UREA-S Kit 420mLRef B45290SRef B24290Model UREA-S Kit 170mL Ref B33290Ref B21490Ref B28290Model UREA-S Kit 312mL
Identity
- Trade Name
- UREA-S Kit EUDAMED
- Device Name
- UREA-S Kit EUDAMED
- Model / Reference
- UREA-S Kit EUDAMEDB21488 EUDAMEDUREA-S Kit 210mL EUDAMEDB33291 EUDAMEDUREA-S Kit 300mL EUDAMEDB29290 EUDAMEDUREA-S Kit 244mL EUDAMEDB34291 EUDAMEDUREA-S Kit 290mL EUDAMEDB35291 EUDAMEDUREA-S Kit 204mL EUDAMEDB21292 EUDAMEDB45291 EUDAMEDB27290S EUDAMEDUREA-S Kit 420mL EUDAMEDB30290 EUDAMEDB45290S EUDAMEDUREA-S Kit 170mL EUDAMEDB24290 EUDAMEDB33290 EUDAMEDB21490 EUDAMEDUREA-S Kit 312mL EUDAMEDB28290 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555625601 EUDAMED08683555616258 EUDAMED08683555615312 EUDAMED08683555616999 EUDAMED08683555602329 EUDAMED08683555623577 EUDAMED08683555622686 EUDAMED08683555622792 EUDAMED08683555614674 EUDAMED08683555622679 EUDAMED08683555613837 EUDAMED08683555616241 EUDAMED08683555625625 EUDAMED08683555619297 EUDAMED08683555615329 EUDAMED
- Basic UDI-DI
- B-08683555625601 EUDAMEDB-08683555616258 EUDAMEDB-08683555615312 EUDAMEDB-08683555616999 EUDAMEDB-08683555602329 EUDAMEDB-08683555623577 EUDAMEDB-08683555622686 EUDAMEDB-08683555622792 EUDAMEDB-08683555614674 EUDAMEDB-08683555622679 EUDAMEDB-08683555613837 EUDAMEDB-08683555616241 EUDAMEDB-08683555625625 EUDAMEDB-08683555619297 EUDAMEDB-08683555615329 EUDAMED
- EMDN Code
- W0101060106 UREA TEST STRIPS EUDAMEDW01010204 UREA/BLOOD UREA NITROGEN 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
UREA-S 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-08683555625601 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (15)
- EUDAMED 93c2701e-dd89-4923-b735-0c211deb4aad 61 fields · synced Oct 5, 2026
- EUDAMED 2ac0a581-965a-4996-980c-1bd898873cd9 61 fields · synced May 16, 2026
- EUDAMED a080fa13-a889-4f32-80c4-3b9bc7ea26d7 61 fields · synced May 16, 2026
- EUDAMED 004e34b7-fcb8-4112-b336-52aef488f0b9 61 fields · synced May 17, 2026
- EUDAMED df3bc9b4-03a8-4fc1-934b-5df8d0945342 61 fields · synced May 17, 2026
- EUDAMED 0fc03699-cfba-4d6e-a096-e85f12e92f76 61 fields · synced May 17, 2026
- EUDAMED c35dd1ff-9fab-4a00-b941-dc424cd54141 61 fields · synced May 17, 2026
- EUDAMED 25601e9c-5da9-4dc2-96f3-7356062c2d69 61 fields · synced May 17, 2026
- EUDAMED 4a58e30a-0f21-46fc-9620-85c809a664f8 61 fields · synced May 18, 2026
- EUDAMED d71dc73b-c364-4e42-b871-8f79a689db03 61 fields · synced May 18, 2026
- EUDAMED 76ec8075-377f-44fe-9171-398c5723983f 61 fields · synced May 18, 2026
- EUDAMED ac479b2e-45ba-4220-a220-91bb4b61747a 61 fields · synced May 18, 2026
- EUDAMED f971a037-809a-4449-b3d6-1bd3e42795f0 61 fields · synced May 19, 2026
- EUDAMED c55241e9-7d4c-4769-836d-a4dd43dc3e5a 61 fields · synced May 19, 2026
- EUDAMED 80959947-acec-471b-bb30-70df6c171dd9 61 fields · synced May 19, 2026