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H series urine analyzer Color Control
EUDAMEDClass IVD General (EU MDR)
Ref 3022356Model 8ml/vial （Blue）Ref 3002397Model 8ml/vial （Green）Ref 3002396Model 8ml/vial （Red）Ref 3022348Model 4×8mL （Green）Ref 3022324Model 4×8mL （Blue）
Identity
- Trade Name
- H series urine analyzer Color Control EUDAMED
- Device Name
- H series urine analyzer Color Control EUDAMED
- Model / Reference
- 8ml/vial （Blue） EUDAMED3022356 EUDAMED8ml/vial （Green） EUDAMED3002397 EUDAMED8ml/vial （Red） EUDAMED3002396 EUDAMED4×8mL （Green） EUDAMED3022348 EUDAMED4×8mL （Blue） EUDAMED3022324 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202204241 EUDAMED06925794504180 EUDAMED06925794504173 EUDAMED06942202204265 EUDAMED06942202204272 EUDAMED
- Basic UDI-DI
- B-06942202204241 EUDAMEDB-06925794504180 EUDAMEDB-06925794504173 EUDAMEDB-06942202204265 EUDAMEDB-06942202204272 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 Color Control 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-06942202204241 | 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 (5)
- EUDAMED 1d987a51-9cf7-4dc0-bc8f-849d42bab44f 61 fields · synced Aug 3, 2026
- EUDAMED 00a84ba1-151b-4567-94ef-1cc5224ee2d2 61 fields · synced May 18, 2026
- EUDAMED cdb76d10-2fd7-40ac-b7e9-6cf2bd42805f 61 fields · synced May 19, 2026
- EUDAMED 2d50b44b-6a0a-4052-a36a-7ad862bd6738 61 fields · synced Jul 19, 2026
- EUDAMED a7df27c5-dfe9-4361-9d2c-eac6ad558b0f 61 fields · synced Aug 3, 2026