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Cholinesterase Assay Kit (DGKC Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020606Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH020610Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH020609Model R1: 60 mL×2; R2: 15 mL×2
Identity
- Device Name
- Cholinesterase Assay Kit (DGKC Method) EUDAMED
- Model / Reference
- R1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH020606 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH020610 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH020609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462480 EUDAMED06975225462534 EUDAMED06975225462510 EUDAMED
- Basic UDI-DI
- B-06975225462480 EUDAMEDB-06975225462534 EUDAMEDB-06975225462510 EUDAMED
- EMDN Code
- W01010111 CHOLINESTERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Cholinesterase Assay Kit (DGKC 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-06975225462480 | 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 (3)
- EUDAMED eacc9fe2-71a6-4d4e-aa9b-df8a8354e6ff 61 fields · synced Jul 21, 2026
- EUDAMED cb73c5d8-f184-4bd0-b93c-c02b28ba4cc1 61 fields · synced May 17, 2026
- EUDAMED 2189b983-ad81-4209-9a54-e0aa32bd664a 61 fields · synced May 19, 2026