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Lactate Dehydrogenase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref LDH6011Y, LDH6012Y, LDH6013Y, LDH6014Y, LDH6015Y, LDH6011N, LDH6012N, LDH6013N, LDH6014N, LDH6015NRef LAC6011Y, LAC6012Y, LAC6013Y, LAC6014Y, LAC6015Y, LAC6011N, LAC6012N, LAC6013N, LAC6014N, LAC6015N
Identity
- Trade Name
- Lactate Dehydrogenase Reagent Kit EUDAMEDLactate Reagent Kit EUDAMED
- Device Name
- Lactate Dehydrogenase Reagent Kit EUDAMEDLactate Reagent Kit EUDAMED
- Model / Reference
- LDH6011Y, LDH6012Y, LDH6013Y, LDH6014Y, LDH6015Y, LDH6011N, LDH6012N, LDH6013N, LDH6014N, LDH6015N EUDAMEDLAC6011Y, LAC6012Y, LAC6013Y, LAC6014Y, LAC6015Y, LAC6011N, LAC6012N, LAC6013N, LAC6014N, LAC6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-LDH601AB EUDAMEDD-LAC60187 EUDAMED
- Basic UDI-DI
- B-LDH601AB EUDAMEDB-LAC60187 EUDAMED
- EMDN Code
- W01010119 LACTATE DEHYDROGENASE L (LDH - L --> P) EUDAMEDW01010218 LACTATE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Lactate Dehydrogenase Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — 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-LDH601AB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (4)
- EUDAMED f4d72e60-93f5-4dad-88ac-bccc812d26ee 61 fields · synced Jul 28, 2026
- EUDAMED f4d72e60-93f5-4dad-88ac-bccc812d26ee-1 61 fields · synced Jun 10, 2026
- EUDAMED 5bf7b5b6-37f9-4832-b563-2d41bcc81769-1 61 fields · synced Jul 28, 2026
- EUDAMED 5bf7b5b6-37f9-4832-b563-2d41bcc81769-2 61 fields · synced Jul 28, 2026