← Back to catalogue
N-Acetyl-Β-D-Glucosaminidase Reagent Kit (mpt-Nag Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3004652Model R1: 2x45mL, R2: 1x30mL, Calibration sample: 1x1mL, Control: 2x1mLRef 3012536Model R1: 2x45mL, R2: 1x30mLRef 3021597Ref 3004423Model R1: 3x50mL, R2: 2x25mLRef 3021521Model 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 EUDAMED3004652 EUDAMEDR1: 2x45mL, R2: 1x30mL EUDAMED3012536 EUDAMED3021597 EUDAMEDR1: 3x50mL, R2: 2x25mL EUDAMED3004423 EUDAMEDR1: 2x45mL, R2: 1x30mL，Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3021521 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246616 EUDAMED06942202259418 EUDAMED06925794591975 EUDAMED06942202246623 EUDAMED06925794591968 EUDAMED
- Basic UDI-DI
- B-06942202246616 EUDAMEDB-06942202259418 EUDAMEDB-06925794591975 EUDAMEDB-06942202246623 EUDAMEDB-06925794591968 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-06942202246616 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 85abb519-892a-4063-8dfc-b586c113f610 61 fields · synced Jul 25, 2026
- EUDAMED 7b653175-cb11-4cb2-93f3-435a62ae4178 61 fields · synced May 17, 2026
- EUDAMED 8c64f07e-9920-468d-b394-04ae6cedc890 61 fields · synced May 18, 2026
- EUDAMED b9847d9d-aa34-40f7-b3ef-26b4dc023af0 61 fields · synced May 19, 2026
- EUDAMED 784e3c7d-a3d6-4927-a8ef-4f421e676c96 61 fields · synced May 19, 2026