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H series urine analyzer Control liquid for Turbidity
EUDAMEDClass IVD General (EU MDR)
Ref 3002400Model 8ml/vial(700NTU)Ref 3022337Model 8ml/vial(200NTU)Ref 3022364
Identity
- Trade Name
- H series urine analyzer Control liquid for Turbidity EUDAMED
- Device Name
- H series urine analyzer Control liquid for Turbidity EUDAMED
- Model / Reference
- 8ml/vial(700NTU) EUDAMED3002400 EUDAMED8ml/vial(200NTU) EUDAMED3022337 EUDAMED3022364 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794573803 EUDAMED06942202204180 EUDAMED06942202204197 EUDAMED
- Basic UDI-DI
- B-06925794573803 EUDAMEDB-06942202204180 EUDAMEDB-06942202204197 EUDAMED
- EMDN Code
- W010106020601 URINE TESTING CONTROLS 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
H series urine analyzer Control liquid for Turbidity 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-06925794573803 | 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 (3)
- EUDAMED 3e036bfc-949d-47e6-aed7-32626ccd15c3 61 fields · synced Jul 9, 2026
- EUDAMED 1a5da574-5780-4248-8997-19ddda4f25ab 61 fields · synced May 18, 2026
- EUDAMED 55e73633-ab41-4cca-a589-0d8ea9965f99 61 fields · synced May 19, 2026