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Lactate Dehydrogenase Assay Kit (Lactate-Pyruvate Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH040407Model R1: 60mL×1; R2: 15mL×1Ref DTSH040402Model R1: 60mL×4; R2: 60mL×1Ref DTSH040406Model R1: 40mL×1; R2: 10mL×1Ref DTSH040408Model R1: 40mL×4; R2: 10mL×4Ref DTSH040405Model R1: 20mL×1; R2: 5mL×1Ref DTSH040403Model R1: 80mL×4; R2: 80mL×1
Identity
- Device Name
- Lactate Dehydrogenase Assay Kit (Lactate-Pyruvate Method) EUDAMED
- Model / Reference
- R1: 60mL×1; R2: 15mL×1 EUDAMEDDTSH040407 EUDAMEDR1: 60mL×4; R2: 60mL×1 EUDAMEDDTSH040402 EUDAMEDR1: 40mL×1; R2: 10mL×1 EUDAMEDDTSH040406 EUDAMEDR1: 40mL×4; R2: 10mL×4 EUDAMEDDTSH040408 EUDAMEDR1: 20mL×1; R2: 5mL×1 EUDAMEDDTSH040405 EUDAMEDR1: 80mL×4; R2: 80mL×1 EUDAMEDDTSH040403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460356 EUDAMED06975225460394 EUDAMED06975225460349 EUDAMED06975225460363 EUDAMED06975225460332 EUDAMED06975225460400 EUDAMED
- Basic UDI-DI
- B-06975225460356 EUDAMEDB-06975225460394 EUDAMEDB-06975225460349 EUDAMEDB-06975225460363 EUDAMEDB-06975225460332 EUDAMEDB-06975225460400 EUDAMED
- EMDN Code
- W01010119 LACTATE DEHYDROGENASE L (LDH - L --> P) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
Lactate Dehydrogenase Assay Kit (Lactate-Pyruvate Method) by Da Te Bioengineering Technology 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-06975225460356 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED bea86f75-8266-4f39-8cca-cc913ed32e71 61 fields · synced Aug 4, 2026
- EUDAMED ff6aefd0-8e7b-44b3-9f31-25d6914e6d9b 61 fields · synced May 16, 2026
- EUDAMED b1e434db-6fc1-438b-86a9-11ff3dec7089 61 fields · synced May 17, 2026
- EUDAMED 5dacdc07-c883-4e54-b9e7-aa28ec839eed 61 fields · synced May 18, 2026
- EUDAMED cb63e2e3-1305-47ab-ae4d-7b2bef053277 61 fields · synced May 18, 2026
- EUDAMED 914e886f-2ea5-49e8-8ecc-fd57bd619ef6 61 fields · synced May 19, 2026