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Urinalysis Multi-Control
EUDAMEDClass IVD General (EU MDR)
Ref 3010243Model Control Level 1: 1×40mL/bottle Control Level 2: 1×40mL/bottle Control Level 3: 1×40mL/bottleRef 3010242Model Control Level 1: 1×15mL/bottle Control Level 2: 1×15mL/bottle Control Level 3: 1×15mL/bottleRef 3010255Model Control Level 1: 1×40mL/bottle Control Level 3: 1×40mL/bottle
Identity
- Trade Name
- Urinalysis Multi-Control EUDAMED
- Device Name
- Urinalysis Multi-Control EUDAMED
- Model / Reference
- Control Level 1: 1×40mL/bottle Control Level 2: 1×40mL/bottle Control Level 3: 1×40mL/bottle EUDAMED3010243 EUDAMEDControl Level 1: 1×15mL/bottle Control Level 2: 1×15mL/bottle Control Level 3: 1×15mL/bottle EUDAMED3010242 EUDAMEDControl Level 1: 1×40mL/bottle Control Level 3: 1×40mL/bottle EUDAMED3010255 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202208959 EUDAMED06942202208942 EUDAMED06925794518637 EUDAMED
- Basic UDI-DI
- B-06942202208959 EUDAMEDB-06942202208942 EUDAMEDB-06925794518637 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
Yes
EUDAMED
Animal Tissues
Yes
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
Urinalysis Multi-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-06942202208959 | 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 da278ad8-28bb-459b-b466-7502c7311395 61 fields · synced Jul 29, 2026
- EUDAMED e4edf8b4-bce1-474b-ac36-73e609b153e9 61 fields · synced May 16, 2026
- EUDAMED 20311b0a-7707-4b3f-ac97-087ec6d894cf 61 fields · synced May 18, 2026