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Goldsite Diagnostics Inc.

China·CN-MF-000001353

Last updated September 18, 2026

What Goldsite Diagnostics Inc. makes

Goldsite Diagnostics Inc. manufactures in vitro diagnostic test kits and calibrators for clinical laboratory use. Their product portfolio includes specific assays for measuring proteins, hormones, and markers such as D-Dimer, HbA1c, IgM, and albumin, alongside dedicated calibrators for these testing systems.

The company is based in China and maintains listings for its products in EUDAMED. These devices are categorized as Class A and IVD General products under the applicable regulatory framework.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of products does Goldsite Diagnostics Inc. manufacture?

Goldsite Diagnostics Inc. manufactures in vitro diagnostic test kits and calibrators designed for clinical laboratory use. Their product portfolio includes specific assays for measuring proteins, hormones, and various markers such as D-Dimer, HbA1c, IgM, and albumin, as well as the necessary calibrators to support these testing systems.

Where is Goldsite Diagnostics Inc. based?

Goldsite Diagnostics Inc. is based in China. This location information is provided as part of the company's regulatory profile to identify the origin of the manufacturer.

How are the devices from Goldsite Diagnostics Inc. classified and where are they listed?

The devices produced by Goldsite Diagnostics Inc. are categorized as Class A and IVD General products. These devices are listed in EUDAMED, which is the European database on medical devices used to provide transparency and information regarding products available within the regulatory framework.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: China
Address: No. 1001, Building No.1, GOLDSITE Mansion, No. 9 Rongtian Road, Shenzhen, China
Website: en.goldsite.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 755 26890807
PRRC Contact: Ji Zhou
EUDAMED SRN: CN-MF-000001353
FDA FEI Number: —
DUNS Number: —

Catalogue (256)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Kemilo T3 Kit	KM17060	EUDAMED	IVD General	Active
SAA Control	SABM052	EUDAMED	IVD General	Active
GPP-100 IgA Kit	GP01020	EUDAMED	IVD General	Active
Nephstar Plus mALB Kit	NP61100	EUDAMED	IVD General	Active
Kemilo 25-OH-VD Control	CC038H	EUDAMED	IVD General	Active
Kemilo CK-MB Kit	KM03060	EUDAMED	IVD General	Active
Omlipo RBP Kit	OP64050	EUDAMED	IVD General	Active
FIA Go LH Kit	FIA35025	EUDAMED	IVD General	Active
lambda-FLC Control Level 1	DM093L	EUDAMED	IVD General	Active
HbA1c Control High Level	HBDM072H	EUDAMED	IVD General	Active
HbA1c Calibrator	HBBZ072	EUDAMED	IVD General	Active
Kemilo FT4 Control	CC016M	EUDAMED	IVD General	Active
Kemilo T4 Control	CC018H	EUDAMED	IVD General	Active
Omlipo AT3 Kit	OP19050	EUDAMED	IVD General	Active
Kemilo PRL Kit	KM30018	EUDAMED	IVD General	Active
Nephstar AT3 Kit	DK019	EUDAMED	IVD General	Active
Omlipo RF Kit	OP23100	EUDAMED	IVD General	Active
Kemilo FT3 Kit	KM15060	EUDAMED	IVD General	Active
Nephstar IgA Kit	DK001	EUDAMED	IVD General	Active
Kemilo FSH Kit	KM25018	EUDAMED	IVD General	Active
SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)	CG123003	EUDAMED	IVD General	Active
Nephstar AMG Kit	DK039	EUDAMED	IVD General	Active
A1c Go HbA1c Kit	AC01025	EUDAMED	IVD General	Active
A1c Go HbA1c Control	HBDMAC1	EUDAMED	IVD General	Active
Nephstar KAP Kit	DK044	EUDAMED	IVD General	Active
lambda-FLC Calibrator	BZ093	EUDAMED	IVD General	Active
HbA2 & HbF & HbA1c Assay Kit (HPLC)	GHD100	EUDAMED	IVD General	Active
Omlipo ASO Kit	OP21050	EUDAMED	IVD General	Active
Cys C Control	DM066	EUDAMED	IVD General	Active
Omlipo AMG Kit	OP39050	EUDAMED	IVD General	Active
kappa-FLC Control Level 1	DM092L	EUDAMED	IVD General	Active
GPP-100 CRP Kit	GP22020	EUDAMED	IVD General	Active
Kemilo FSH Kit	KM25060	EUDAMED	IVD General	Active
Nephstar HPT Kit	DK016	EUDAMED	IVD General	Active
Nephstar RBP Kit	DK064	EUDAMED	IVD General	Active
Kemilo FSH Control	CC025M	EUDAMED	IVD General	Active
Nephstar LAM Kit	DK045	EUDAMED	IVD General	Active
Anti-CCP Control Level 1	DM026L	EUDAMED	IVD General	Active
Specific Protein Analyzer	Omlipo	EUDAMED	Class A	Active
BMG Calibrator	BZ062	EUDAMED	IVD General	Active
FIA Go β-HCG Kit	FIA20025	EUDAMED	IVD General	Active
Apo A1 Calibrator	BZ041	EUDAMED	IVD General	Active
GPP-100 IgG Kit	GP04020	EUDAMED	IVD General	Active
Kemilo FT4 Control	CC016L	EUDAMED	IVD General	Active
Kemilo IL-6 Control	CC011M	EUDAMED	IVD General	Active
Nephstar A1M Kit	DK063	EUDAMED	IVD General	Active
Automatic HPLC HbA1c Analyzer	GSH-50	EUDAMED	Class A	Active
Kemilo TSH Kit	KM13060	EUDAMED	IVD General	Active
G-3DIL Diluent	G-3DIL	EUDAMED	Class A	Active
Omlipo RBP Kit	OP64100	EUDAMED	IVD General	Active

Related Companies

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CMC Medical Devices & Drugs SL ES

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