Is this your brand? Sign in to claim ownership.

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 3 of 6

Device	Model / Reference	Registries	Class	Status
GPP-100 C4 Kit	GP34020	EUDAMED	IVD General	Active
FIA Go 25-OH-VD Kit	FIA122024	EUDAMED	IVD General	Active
Omlipo Apo B Kit	OP42050	EUDAMED	IVD General	Active
HbA2 & HbF & HbA1c Control	GHDDM1	EUDAMED	IVD General	Active
Kemilo IL-6 Kit	KM11060	EUDAMED	IVD General	Active
GPP-100 SAA Kit	GP52020	EUDAMED	IVD General	Active
Omlipo HbA1c Kit	OP71050	EUDAMED	IVD General	Active
Omlipo C3 Kit	OP33100	EUDAMED	IVD General	Active
Omlipo C4 Kit	OP34050	EUDAMED	IVD General	Active
Omlipo IgA Kit	OP01100	EUDAMED	IVD General	Active
Urine IgG Control	DM067	EUDAMED	IVD General	Active
D-Dimer Calibrator	DDBZ065	EUDAMED	IVD General	Active
Omlipo bCRP Kit	OP51100	EUDAMED	IVD General	Active
Apo B Calibrator	BZ042	EUDAMED	IVD General	Active
CRP Control M	CPZK105	EUDAMED	IVD General	Active
FIA Go FERR Kit	FIA86025	EUDAMED	IVD General	Active
Kemilo cTnI Kit	KM01060	EUDAMED	IVD General	Active
Kemilo PROG Kit	KM08060	EUDAMED	IVD General	Active
Solution C	CL00318	EUDAMED	Class A	Active
Omlipo Cys C Kit	OP66050	EUDAMED	IVD General	Active
Omlipo D-Dimer Kit	OP65050	EUDAMED	IVD General	Active
Omlipo Kappa-FLC Kit	OP92100	EUDAMED	IVD General	Active
Kemilo D-Dimer Control	CC010H	EUDAMED	IVD General	Active
Kemilo T4 Control	CC018L	EUDAMED	IVD General	Active
Kemilo T4 Control	CC018M	EUDAMED	IVD General	Active
RBP Calibrator	BZ064	EUDAMED	IVD General	Active
D-Dimer Control	DDDM065	EUDAMED	IVD General	Active
Cys C Calibrator	BZ066	EUDAMED	IVD General	Active
RF Calibrator	RFBZ023	EUDAMED	IVD General	Active
Nephstar CER Kit	DK018	EUDAMED	IVD General	Active
Nephstar C3 Kit	DK033	EUDAMED	IVD General	Active
Kemilo LH Control	CC027H	EUDAMED	IVD General	Active
FIA Go Free T4 Kit	FIA29025	EUDAMED	IVD General	Active
SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)	CG123005	EUDAMED	IVD General	Active
G-3LHB Lyse	G-3LHB	EUDAMED	Class A	Active
GPP-100 C3 Kit	GP33020	EUDAMED	IVD General	Active
GPP-100 Urine IgG Kit	GP67020	EUDAMED	IVD General	Active
FIA Go TSH Kit	FIA21025	EUDAMED	IVD General	Active
Kemilo Myo Kit	KM02060	EUDAMED	IVD General	Active
CRP Control L	CPZK205	EUDAMED	IVD General	Active
mALB Calibrator	MABZ061	EUDAMED	IVD General	Active
FIA Go PCT Kit	FIA07025	EUDAMED	IVD General	Active
FIA Go SAA Kit	FIA39025	EUDAMED	IVD General	Active
GPP-100 D-Dimer Kit	GP65020	EUDAMED	IVD General	Active
Solution B	BL00230	EUDAMED	Class A	Active
Kemilo Tβ-HCG Control	CC009M	EUDAMED	IVD General	Active
Nephstar C4 Kit	DK034	EUDAMED	IVD General	Active
Kemilo LH Kit	KM27018	EUDAMED	IVD General	Active
GPP-100 LAM Kit	GP45020	EUDAMED	IVD General	Active
Omlipo C1IN Kit	OP36050	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

CMC Medical Devices & Drugs SL ES

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.