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H series urine analyzer Control liquid for Specific gravity
EUDAMEDClass IVD General (EU MDR)
Ref 3002390Model 8ml/vial （1.005）Ref 3002392Model 8ml/vial （1.050）Ref 3022331
Identity
- Trade Name
- H series urine analyzer Control liquid for Specific gravity EUDAMED
- Device Name
- H series urine analyzer Control liquid for Specific gravity EUDAMED
- Model / Reference
- 8ml/vial （1.005） EUDAMED3002390 EUDAMED8ml/vial （1.050） EUDAMED3002392 EUDAMED3022331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794504241 EUDAMED06925794504265 EUDAMED06942202204302 EUDAMED
- Basic UDI-DI
- B-06925794504241 EUDAMEDB-06925794504265 EUDAMEDB-06942202204302 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 Specific gravity 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-06925794504241 | 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 ff2b0afe-0267-413f-8e45-225de00f4058 61 fields · synced Aug 3, 2026
- EUDAMED ac670009-c291-40ec-82e0-dab3dd1dde37 61 fields · synced May 18, 2026
- EUDAMED f793766e-d633-46c1-8aeb-5cdc48f7cdda 61 fields · synced May 19, 2026