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Results for “Fully automatic chemiluminescence immunoassay analyzer”

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Registry EUDAMED 9 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) 6

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Romania 4 Italy 2

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

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Class A 9 Class B Class C Class D IVD General 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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9 devices foundsorted by relevance

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Fully automatic chemiluminescence immunoassay analyzer UDI-DI 06974576209867

Guangzhou KOFA Biotechnology Co., Ltd.,China Class A

Active CE IVDR EUDAMED A
4 variants
- Fully automatic chemiluminescence immunoassay analyzer 2FF00001
- Fully automatic chemiluminescence immunoassay analyzer 2FF00005
- Fully automatic chemiluminescence immunoassay analyzer 2FF00008
Fully-Automatic Chemiluminescence Immunoassay Analyzer UDI-DI 06973597100535

Xiamen United Medical Instruments Co., Ltd.,China Class A

Active CE IVDR EUDAMED A
3 variants
- Fully-Automatic Chemiluminescence Immunoassay Analyzer Wan200+ A
- Fully-Automatic Chemiluminescence Immunoassay Analyzer Wan200+ S
Fully Automatic Chemiluminescence Immunoassay Analyzer UDI-DI 06971792050099

Hangzhou Realy Tech Co., Ltd.,China Class A

Active CE IVDR EUDAMED A
2 variants
- Fully Automatic Chemiluminescence Immunoassay Analyzer RL-C4000

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