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ALT (SGPT) Kit
EUDAMEDClass IVD General (EU MDR)
Ref B28015Model ALT (SGPT) Kit 312mLRef B33015Model ALT (SGPT) Kit 420mLRef B30015Model ALT (SGPT) Kit 420mL Ref B28016Model ALT (SGPT) Kit 117mLRef B24016Model ALT (SGPT) Kit 244mLRef B45016Model ALT (SGPT) Kit 240mLRef B30016Model ALT (SGPT) Kit 210mL Ref B29016Model ALT (SGPT) Kit 225mLRef B29015Model ALT (SGPT) Kit 105mL
Identity
- Trade Name
- ALT (SGPT) Kit EUDAMED
- Device Name
- ALT (SGPT) Kit EUDAMED
- Model / Reference
- ALT (SGPT) Kit 312mL EUDAMEDB28015 EUDAMEDALT (SGPT) Kit 420mL EUDAMEDB33015 EUDAMEDB30015 EUDAMEDALT (SGPT) Kit 117mL EUDAMEDB28016 EUDAMEDALT (SGPT) Kit 244mL EUDAMEDB24016 EUDAMEDALT (SGPT) Kit 240mL EUDAMEDB45016 EUDAMEDALT (SGPT) Kit 210mL EUDAMEDB30016 EUDAMEDALT (SGPT) Kit 225mL EUDAMEDB29016 EUDAMEDALT (SGPT) Kit 105mL EUDAMEDB29015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555618429 EUDAMED08683555615473 EUDAMED08683555613912 EUDAMED08683555618436 EUDAMED08683555616357 EUDAMED08683555622112 EUDAMED08683555613929 EUDAMED08683555614780 EUDAMED08683555614773 EUDAMED
- Basic UDI-DI
- B-08683555618429 EUDAMEDB-08683555615473 EUDAMEDB-08683555613912 EUDAMEDB-08683555618436 EUDAMEDB-08683555616357 EUDAMEDB-08683555622112 EUDAMEDB-08683555613929 EUDAMEDB-08683555614780 EUDAMEDB-08683555614773 EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE 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
ALT (SGPT) 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-08683555618429 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (9)
- EUDAMED 2b4723c0-6971-4e28-973b-7c7f463f5af4 61 fields · synced Oct 6, 2026
- EUDAMED 93f865e6-cbfa-46e3-8ed7-b9a1f9b8a336 61 fields · synced May 17, 2026
- EUDAMED b688b095-e5f3-4ed4-8e2f-3970a16a0737 61 fields · synced May 17, 2026
- EUDAMED f77e5298-fc36-46f9-a891-b929e9c68402 61 fields · synced May 17, 2026
- EUDAMED a6403c0e-3f7c-46c3-ad40-91b084f64e5c 61 fields · synced May 18, 2026
- EUDAMED 8cdf8227-923d-460d-8aa1-8dc1fe8aaea3 61 fields · synced May 18, 2026
- EUDAMED e73feb02-f1ea-4260-80c8-93a201fb81df 61 fields · synced May 18, 2026
- EUDAMED 47ff8afe-c13c-4993-9bfb-e53ab8bdfcdf 61 fields · synced May 18, 2026
- EUDAMED ea646cd7-2361-4722-ae45-29a5c6047dd8 61 fields · synced May 19, 2026