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Lactate Dehydrogenase (LDH) Assay Kit (Lactate Method)
EUDAMEDClass IVD General (EU MDR)
Ref 106H60TSCRef 106H240TRef 106H240TSC
Identity
- Trade Name
- Lactate Dehydrogenase (LDH) Assay Kit (Lactate Method) EUDAMED
- Device Name
- Lactate Dehydrogenase (LDH) Assay Kit (Lactate Method) EUDAMED
- Model / Reference
- 106H60TSC EUDAMED106H240T EUDAMED106H240TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-106H60TSC3X EUDAMEDD-106H240TFL EUDAMEDD-106H240TSCKA EUDAMED
- Basic UDI-DI
- B-106H60TSC3X EUDAMEDB-106H240TFL EUDAMEDB-106H240TSCKA EUDAMED
- EMDN Code
- W01010119 LACTATE DEHYDROGENASE L (LDH - L --> P) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Lactate Dehydrogenase (LDH) Assay Kit (Lactate Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-106H60TSC3X | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED a9a591a1-ba94-4972-9fab-3901cd27f375 61 fields · synced Oct 6, 2026
- EUDAMED 102ae2f2-8365-4ffc-a462-aa044e7043c5 61 fields · synced May 17, 2026
- EUDAMED d85962ee-8e38-4a65-be25-a53d57098f1a 61 fields · synced May 18, 2026