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Results for “Urinalysis Analyzer”

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Registry EUDAMED 19 FDA 510(k) 5 FDA PMA GUDID 1

Country / market European Union (all) 19 United States 6

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Risk class Class I 2 Class IIa Class IIb Class III Class II (US) 4

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Class A 5 Class B Class C Class D IVD General 14 IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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25 devices foundsorted by relevance

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Urinalysis Reagent Strips for Urine Analyzer UDI-DI D-D-U8MC100AUBZ

Rapid Labs Ltd,United Kingdom

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
14 variants
- Urinalysis Reagent Strips for Urine Analyzer D-U1MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U2MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U3MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U4MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U5MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U6MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U7MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U9MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U10MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U11MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U12MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U13MC100AU
- Urinalysis Reagent Strips for Urine Analyzer D-U14MC100AU
Urinalysis Analyzer UDI-DI 06977338230024

Newlink Biotech co., Ltd.,China

Active Regimes: CE IVDR Registry: EUDAMED Class:A
4 variants
- Urinalysis Analyzer C21-UA100
- Urinalysis Analyzer C21-UA300
- Urinalysis Analyzer C21-UA400
Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software UF-1000i with UF WAM

Sysmex America, Inc.,FDA registration: United States

Withdrawn Registry: GUDID Class:II
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )

Acon Laboratories, Inc.,United States

Active Regimes: 510(k) Registry: 510(k) Class:II

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