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Urinalysis Control
EUDAMEDClass IVD General (EU MDR)
Ref 3022334Model 4×8mL (Positive)Ref 3022363Model 8ml/bottle (Positive)Ref 3022328Model 8ml/bottle (Negative)Ref 3002462Ref 3002463
Identity
- Trade Name
- Urinalysis Control EUDAMED
- Device Name
- Urinalysis Control EUDAMED
- Model / Reference
- 4×8mL (Positive) EUDAMED3022334 EUDAMED8ml/bottle (Positive) EUDAMED3022363 EUDAMED8ml/bottle (Negative) EUDAMED3022328 EUDAMED3002462 EUDAMED3002463 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202204104 EUDAMED06942202204081 EUDAMED06942202204098 EUDAMED06925794505033 EUDAMED06925794505019 EUDAMED
- Basic UDI-DI
- B-06942202204104 EUDAMEDB-06942202204081 EUDAMEDB-06942202204098 EUDAMEDB-06925794505033 EUDAMEDB-06925794505019 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
Yes
EUDAMEDEUDAMED
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
Urinalysis 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-06942202204104 | 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 8c1e088b-39a6-4fd4-ad85-ca0a64df8e48 61 fields · synced Jul 29, 2026
- EUDAMED 84d12a60-cf52-488e-bb9c-021a831a7dff 61 fields · synced May 16, 2026
- EUDAMED e44b9cd1-229e-4e47-979d-331665840eb0 61 fields · synced May 17, 2026
- EUDAMED 1749fb87-3a8f-49c4-b98a-5caeceb3656d 61 fields · synced May 17, 2026
- EUDAMED 989b9162-7625-4b2e-82e7-1796ad7e7cdc 61 fields · synced May 18, 2026