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N-Acetyl-β-D-Glucosaminidase Kit (MPT Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ016YModel 60mL（R1:1×45mL+R2:1×15mL）
Identity
- Trade Name
- N-Acetyl-β-D-Glucosaminidase Kit (MPT Method) EUDAMED
- Device Name
- N-Acetyl-β-D-Glucosaminidase Kit (MPT Method) EUDAMED
- Model / Reference
- 60mL（R1:1×45mL+R2:1×15mL） EUDAMEDMJ016Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595751857 EUDAMED
- Basic UDI-DI
- B-06936595751857 EUDAMED
- EMDN Code
- W01010126 N-ACETYL-B, D-GLUCOSAMINIDASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
N-Acetyl-β-D-Glucosaminidase Kit (MPT Method) by Medicalsystem Biotechnology 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-06936595751857 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 88dde182-0e98-4dc2-8060-06691258e02c 61 fields · synced Jul 16, 2026