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Automatic Urinalysis System
EUDAMEDClass B (EU MDR)
Ref EHU9101007Model U 2000, U 2000S
Identity
- Trade Name
- Automatic Urinalysis System EUDAMED
- Device Name
- Automatic Urinalysis System EUDAMED
- Model / Reference
- U 2000, U 2000S EUDAMEDEHU9101007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168352106 EUDAMED
- Basic UDI-DI
- 6972168352201A3 EUDAMED
- Direct Marketing DI
- 06972168352106 EUDAMED
- EMDN Code
- W020101020103 AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Urinalysis System by Maccura Medical Instrument Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6972168352201A3 | Class B | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 3dc0e6fd-6bf5-4c0b-9b7f-91d0e7bfdf11 61 fields · synced Oct 7, 2026