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Sodium Reagent Kit(Galactosidase Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3016007Model R1: 1x45mL, R2: 1x15mLRef 3015850Model R1: 2x60mL, R2: 2x20mLRef 3021730Ref 3021626Model R1: 2x60mL, R2: 2x20mL, Calibration sample: 2x1mL,
Identity
- Trade Name
- Sodium Reagent Kit(Galactosidase Assay) EUDAMED
- Device Name
- Sodium Reagent Kit(Galactosidase Assay) EUDAMED
- Model / Reference
- R1: 1x45mL, R2: 1x15mL EUDAMED3016007 EUDAMEDR1: 2x60mL, R2: 2x20mL EUDAMED3015850 EUDAMED3021730 EUDAMEDR1: 2x60mL, R2: 2x20mL, Calibration sample: 2x1mL, EUDAMED3021626 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261367 EUDAMED06942202260452 EUDAMED06925794592910 EUDAMED06925794592927 EUDAMED
- Basic UDI-DI
- B-06942202261367 EUDAMEDB-06942202260452 EUDAMEDB-06925794592910 EUDAMEDB-06925794592927 EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - 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
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
Sodium Reagent Kit(Galactosidase Assay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202261367 | 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 da35876a-feef-4636-9a5b-0c4068f84770 61 fields · synced Aug 2, 2026
- EUDAMED ebeef16a-a518-4c56-816b-ba05a1eb3ece 61 fields · synced May 16, 2026
- EUDAMED d526a45a-6716-4578-b10e-24fff954f227 61 fields · synced Jul 16, 2026
- EUDAMED ebd4dacf-b314-4d32-8023-613424515866 61 fields · synced Aug 2, 2026