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Results for “Glucose Analyzer”

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Registry EUDAMED 68 FDA 510(k) 26 FDA PMA GUDID 5

Country / market European Union (all) 57 United States 31

More countries (18)

Germany 21 Spain 10 Sweden 5 Poland 4 France 3 Denmark 2 Ireland 2 Norway 2 Portugal 2 Czechia 1 Estonia 1 Greece 1 Finland 1 Croatia 1 Iceland 1 Netherlands 1 Romania 1 Slovenia 1

Risk class Class I 5 Class IIa Class IIb Class III Class II (US) 25

More classes (11)

Class A 63 Class B Class C Class D IVD General 4 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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98 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

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Registry

Class

Glucose/Ketone/Uric Acid/Total Cholesterol Analyzer UDI-DI 06977338230048

Newlink Biotech co., Ltd.,China

Active Regimes: CE IVDR Registry: EUDAMED Class:A
2 variants
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HemoCue Glucose 201 DM Analyzer UDI-DI 07311091214393

Hemocue Ab,Sweden

Active Regimes: CE IVDR Registry: EUDAMED Class:A
17 variants
- HemoCue Glucose 201 DM Analyzer 121420
- HemoCue Glucose 201 DM Analyzer 121421
- HemoCue Glucose 201 DM Analyzer 121423
- HemoCue Glucose 201 DM Analyzer 121434
- HemoCue Glucose 201 DM Analyzer 121440
- HemoCue Glucose 201 DM Analyzer 121442
- HemoCue Glucose 201 DM Analyzer 121446
- HemoCue Glucose 201 DM Analyzer 121453
- See all variants of this device
HemoCue Glucose 201 DM RT Analyzer UDI-DI 07311091240088

Hemocue Ab,Sweden

Active Regimes: CE IVDR Registry: EUDAMED Class:A
14 variants
HemoCue Glucose 201 RT Analyzer UDI-DI 07311091247087

Hemocue Ab,Sweden

Active Regimes: CE IVDR Registry: EUDAMED Class:A
11 variants
- HemoCue Glucose 201 RT Analyzer 124703
- HemoCue Glucose 201 RT Analyzer 124711
- HemoCue Glucose 201 RT Analyzer 124741
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HemoCue Glucose 201+ Analyzer UDI-DI 07311091207142

Hemocue Ab,Sweden

Active Regimes: CE IVDR Registry: EUDAMED Class:A
11 variants
- HemoCue Glucose 201+ Analyzer 120754
- See all variants of this device
Glucose Analyzer UDI-DI 06977338230123

Newlink Biotech co., Ltd.,China

Active Regimes: CE IVDR Registry: EUDAMED Class:A
2 variants
- See all variants of this device

Showing 21-40 of 98

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