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Phosphorus Enzymatic Kit
EUDAMEDClass IVD General (EU MDR)
Ref B28256Model Phosphorus Enzymatic Kit 90mLRef B28255Model Phosphorus Enzymatic Kit 240mL
Identity
- Trade Name
- Phosphorus Enzymatic Kit EUDAMED
- Device Name
- Phosphorus Enzymatic Kit EUDAMED
- Model / Reference
- Phosphorus Enzymatic Kit 90mL EUDAMEDB28256 EUDAMEDPhosphorus Enzymatic Kit 240mL EUDAMEDB28255 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555619174 EUDAMED08683555619167 EUDAMED
- Basic UDI-DI
- B-08683555619174 EUDAMEDB-08683555619167 EUDAMED
- EMDN Code
- W01010307 PHOSPHATE INORGANIC / PHOSPHORUS 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
Category: Inorganic phosphate (PO43-) IVD, reagent
Phosphorus Enzymatic Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Inorganic phosphate (PO43-) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Phosphorus UV, 2 x 100 mL — Chronolab Systems, S.L. · IVD General
- Liquick Cor-PHOSPHORUS 30 — PZ CORMAY Spółka Akcyjna · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Pointe Scientific, Inc. Phosphorus — POINTE SCIENTIFIC, INC. · Class I
- ACCENT-300 PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
- Alinity — Abbott · Class I
- Fosforo UV — GIESSE DIAGNOSTICS SRL · IVD General
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-08683555619174 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (2)
- EUDAMED 7e6e0644-882e-4a6f-ab5b-ceb83b796588 61 fields · synced Jul 9, 2026
- EUDAMED 89308193-64cf-45f8-a6eb-74a7541ed0f3 61 fields · synced May 18, 2026