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Xiamen Innodx Biotech Co., Ltd.

China·CN-MF-000041071

Last updated September 18, 2026

Information

Country: China
Address: 1/F, No.9-1, Hutou Road, Xiamen, China
Website: www.innodx.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 0592-6807333
PRRC Contact: Yinhua He
EUDAMED SRN: CN-MF-000041071
FDA FEI Number: —
DUNS Number: —

Catalogue (160)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
INNODX iPTH CMIA	KR-iPTH-02200	EUDAMED	IVD General	Active
Innodx Tt3 Cmia	KR-TT3-02200	EUDAMED	IVD General	Active
Innodx Tb-Igra Cmia	KR-TB-IGRA-01020C	EUDAMED	IVD General	Active
Innodx Pivka-Ii Cmia	KR-PIVKA-II-02200	EUDAMED	IVD General	Active
Innodx Ca242 Cmia	KR-CA242-01100C	EUDAMED	IVD General	Active
Innodx Piiinp Cmia	KR-PⅢNP-01100C	EUDAMED	IVD General	Active
Innodx Ck-Mb Stat Cmia	KR-CK-MB STAT-02200	EUDAMED	IVD General	Active
Innodx Tsh Cmia	KR-TSH-02300	EUDAMED	IVD General	Active
Innodx Ck-Mb Stat Cmia	KR-CK-MB-03100	EUDAMED	IVD General	Active
Innodx Ca50 Cmia	KR-CA50-01100C	EUDAMED	IVD General	Active
INNODX Insulin CMIA	KR-Insulin-01100C	EUDAMED	IVD General	Active
Innodx Pivka-Ii Cmia	KR-PIVKA-II-02100	EUDAMED	IVD General	Active
Innodx 25-Oh-Vd Cmia	KR-25-OH-VD-0250	EUDAMED	IVD General	Active
Innodx Tt3 Cmia	KR-TT3-01100C	EUDAMED	IVD General	Active
Innodx E2 Cmia	KR-E2-01100C	EUDAMED	IVD General	Active
Innodx Ft3 Cmia	KR-FT3-01200	EUDAMED	IVD General	Active
INNODX iPTH CMIA	KR-iPTH-01100	EUDAMED	IVD General	Active
INNODX ProGRP CMIA	KR-ProGRP-0250	EUDAMED	IVD General	Active
Innodx Tt4 Cmia	KR-TT4-03100	EUDAMED	IVD General	Active
Innodx Fsh Cmia	KR-FSH-01100C	EUDAMED	IVD General	Active
INNODX Hs-cTnT STAT CMIA	KR-Hs-cTnT STAT-02200	EUDAMED	IVD General	Active
Liver Fibrosis (Lyophilized) Control	Liver Fibrosis CON	EUDAMED	IVD General	Active
Innodx T-Psa Cmia	KR-T-PSA-0250	EUDAMED	Class C	Active
Innodx T-Psa Cmia	KR-T-PSA-01100	EUDAMED	Class C	Active
Innodx St2 Stat Cmia	KR-ST2 STAT-02200	EUDAMED	Class C	Active
Pre-trigger Solution	KR-PTS-01500C	EUDAMED	Class A	Active
Innodx T-Psa Cmia	KR-T-PSA-0150	EUDAMED	Class C	Active
INNODX Hs-cTnT STAT CMIA	KR-Hs-cTnT STAT-02100	EUDAMED	Class C	Active
Innodx St2 Stat Cmia	KR-ST2 STAT-0250	EUDAMED	Class C	Active
Concentrated Wash Solution	KR-CWS-01500	EUDAMED	Class A	Active
Innodx Pivka-Ii Cmia	KR-PIVKA-Ⅱ -02200	EUDAMED	Class C	Active
Innodx T-Psa Cmia	KR-T-PSA-02100	EUDAMED	Class C	Active
Innodx Pivka-Ii Cmia	KR-PIVKA-Ⅱ -0450	EUDAMED	Class C	Active
Innodx T-Psa Cmia	KR-T-PSA-01200	EUDAMED	Class C	Active
Innodx Pivka-Ii Cmia	KR-PIVKA-Ⅱ -02100	EUDAMED	Class C	Active
Concentrated Wash Solution	KR-CWS-01500C	EUDAMED	Class A	Active
Innodx Pivka-Ii Cmia	KR-PIVKA-Ⅱ -0250	EUDAMED	Class C	Active
INNODX ProGRP CMIA	KR-ProGRP-0450	EUDAMED	Class C	Active
Innodx Ck-Mb Stat Cmia	KR-CK-MB STAT-0350	EUDAMED	Class C	Active
Reaction Cup	PRC-01	EUDAMED	Class A	Active
INNODX f-PSA CMIA	KR-f-PSA-02100	EUDAMED	Class C	Active
Diluent Universal	KR-DU-01200	EUDAMED	Class A	Active
Pre-trigger Solution	KR-PTS-01200	EUDAMED	Class A	Active
Innodx Nbnp Stat Cmia	KR-NBNP-03100	EUDAMED	Class C	Active
Diluent Universal	KR-DU-01200C	EUDAMED	Class A	Active
INNODX Myo STAT CMIA	KR-Myo STAT-02100	EUDAMED	Class C	Active
INNODX Hs-cTnT STAT CMIA	KR-Hs-cTnT STAT-0250	EUDAMED	Class C	Active
Reaction Cup	PRC-03	EUDAMED	Class A	Active
Innodx Ck-Mb Stat Cmia	KR-CK-MB-03100	EUDAMED	Class C	Active
Trigger Solution	KR-TS-01200	EUDAMED	Class A	Active

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