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Sign in to claim this brandGoldsite 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
- —
- —
- [email protected]
- Phone
- +86 755 26890807
- PRRC Contact
- Ji Zhou
- EUDAMED SRN
- CN-MF-000001353
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (256)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GPP-100 UsCRP Kit | GP25020 | EUDAMED | IVD General | Active |
| HbA1c Control | HBDM072 | EUDAMED | IVD General | Active |
| Omlipo Lambda-FLC Kit | OP93050 | EUDAMED | IVD General | Active |
| Omlipo mALB Kit | OP61050 | EUDAMED | IVD General | Active |
| Omlipo IgM Kit | OP09050 | EUDAMED | IVD General | Active |
| Kemilo Tβ-HCG Control | CC009H | EUDAMED | IVD General | Active |
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