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Cholinsterase Reagent Kit（butyryl Thiocholine Substrate Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3016563Model R1: 4x50mL, R2: 1x50mLRef 3023559Ref 3005691Model R1: 4x50mL, R2: 2x25mLRef 3016512
Identity
- Trade Name
- CHOLINSTERASE REAGENT KIT（BUTYRYL THIOCHOLINE SUBSTRATE METHOD） EUDAMED
- Device Name
- CHOLINSTERASE REAGENT KIT（BUTYRYL THIOCHOLINE SUBSTRATE METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL EUDAMED3016563 EUDAMED3023559 EUDAMEDR1: 4x50mL, R2: 2x25mL EUDAMED3005691 EUDAMED3016512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202258862 EUDAMED06942202215681 EUDAMED06942202257391 EUDAMED06942202258855 EUDAMED
- Basic UDI-DI
- B-06942202258862 EUDAMEDB-06942202215681 EUDAMEDB-06942202257391 EUDAMEDB-06942202258855 EUDAMED
- EMDN Code
- W01010111 CHOLINESTERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Cholinsterase Reagent Kit（butyryl Thiocholine Substrate Method） by Dirui Industrial 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-06942202258862 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED b5d209fa-38c6-4f22-b7c5-411de5f28800 61 fields · synced Jul 19, 2026
- EUDAMED 69851b82-b631-49dc-b349-e49e85ca7f21 61 fields · synced May 17, 2026
- EUDAMED c7bcd072-c025-4629-9e10-45bb9b13da36 61 fields · synced May 18, 2026
- EUDAMED d22bfc24-e4fe-4d5b-96a1-ce3d271e21a6 61 fields · synced May 19, 2026