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LDH-S Kit
EUDAMEDClass IVD General (EU MDR)
Ref B29215Model LDH-S Kit 105mLRef B27215Model LDH-S Kit 420mL Ref B30215Model LDH-S Kit 210mLRef B45308Model LDH-S Kit Ref B355215Model LDH-S Kit 180mLRef B33215Model LDH-S Kit 420mLRef B34215Model LDH-S Kit 183mLRef B33216
Identity
- Trade Name
- LDH-S Kit EUDAMED
- Device Name
- LDH-S Kit EUDAMED
- Model / Reference
- LDH-S Kit 105mL EUDAMEDB29215 EUDAMEDLDH-S Kit 420mL EUDAMEDB27215 EUDAMEDLDH-S Kit 210mL EUDAMEDB30215 EUDAMEDLDH-S Kit EUDAMEDB45308 EUDAMEDLDH-S Kit 180mL EUDAMEDB355215 EUDAMEDB33215 EUDAMEDLDH-S Kit 183mL EUDAMEDB34215 EUDAMEDB33216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555615169 EUDAMED08683555612960 EUDAMED08683555614476 EUDAMED08683555691132 EUDAMED08683555617484 EUDAMED08683555616036 EUDAMED08683555616784 EUDAMED08683555616043 EUDAMED
- Basic UDI-DI
- B-08683555615169 EUDAMEDB-08683555612960 EUDAMEDB-08683555614476 EUDAMEDB-08683555691132 EUDAMEDB-08683555617484 EUDAMEDB-08683555616036 EUDAMEDB-08683555616784 EUDAMEDB-08683555616043 EUDAMED
- EMDN Code
- W01010119 LACTATE DEHYDROGENASE L (LDH - L --> P) EUDAMEDW01010121 LACTATE DEHYDROGENASE ISOENZYMES 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
LDH-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-08683555615169 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (8)
- EUDAMED 6805fda4-a17f-42e0-8236-c2be33f2be63 61 fields · synced Oct 6, 2026
- EUDAMED 446d8b09-fa8c-4551-a8b8-efa02dc5ab25 61 fields · synced May 16, 2026
- EUDAMED 631dac73-ef8d-4be2-8aa3-36d58eb6ddaf 61 fields · synced May 17, 2026
- EUDAMED 86579871-7f45-4838-94cf-195e3d051d41 61 fields · synced May 17, 2026
- EUDAMED 0bc5db72-bfa3-4f71-a816-ca08b3ac7365 61 fields · synced May 17, 2026
- EUDAMED e60fbb3e-6862-4242-93e9-5bf9d08a73df 61 fields · synced May 18, 2026
- EUDAMED b5b6f066-a359-46c6-b34c-fd3d435fa6b4 61 fields · synced May 18, 2026
- EUDAMED c8ba8cd8-8780-4c12-9638-d906e82a655a 61 fields · synced May 19, 2026