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Leucine Aminopeptidase Reagent Kit（substrate Hydrolysis）
EUDAMEDClass IVD General (EU MDR)
Ref 3001623Model R1: 4x50mL, R2: 1x50mLRef 3021535Model R1: 4x50mL, R2: 2x25mL
Identity
- Trade Name
- LEUCINE AMINOPEPTIDASE REAGENT KIT（SUBSTRATE HYDROLYSIS） EUDAMED
- Device Name
- LEUCINE AMINOPEPTIDASE REAGENT KIT（SUBSTRATE HYDROLYSIS） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL EUDAMED3001623 EUDAMEDR1: 4x50mL, R2: 2x25mL EUDAMED3021535 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246470 EUDAMED06925794592781 EUDAMED
- Basic UDI-DI
- B-06942202246470 EUDAMEDB-06925794592781 EUDAMED
- EMDN Code
- W01010122 LEUCINE AMINOPEPTIDASE 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
Yes
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
Leucine Aminopeptidase Reagent Kit（substrate Hydrolysis） 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-06942202246470 | 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 (2)
- EUDAMED 0279a6d5-3ee8-4624-b130-24814701cf40 61 fields · synced Jul 10, 2026
- EUDAMED 70fa7949-6373-4d68-845b-e8742bdb9970 61 fields · synced May 17, 2026