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N-Acetyl-Β-D-Glucosaminidase Reagent Kit (mpt-Nag Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3021154Model R1: 2x45mL, R2: 1x30mL，Calibration sample: 1x1mL, Control: 2x1mL
Identity
- Trade Name
- N-ACETYL-β-D-GLUCOSAMINIDASE REAGENT KIT (MPT-NAG METHOD) EUDAMED
- Device Name
- N-ACETYL-β-D-GLUCOSAMINIDASE REAGENT KIT (MPT-NAG METHOD) EUDAMED
- Model / Reference
- R1: 2x45mL, R2: 1x30mL，Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3021154 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259401 EUDAMED
- Basic UDI-DI
- B-06942202259401 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER 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
N-Acetyl-Β-D-Glucosaminidase Reagent Kit (mpt-Nag 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-06942202259401 | 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 (1)
- EUDAMED f7710699-699a-4189-87f5-86eaf8717e76 61 fields · synced Jun 19, 2026