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Hangzhou Realy Tech Co.,Ltd.

China·CN-MF-000004716

Last updated May 23, 2026

What Hangzhou Realy Tech Co.,Ltd. makes

Hangzhou Realy Tech Co.,Ltd. produces in vitro diagnostic (IVD) reagents and rapid test devices for various biomarkers including cardiac troponin I, pepsinogen I, HER-2, M. pneumoniae antigen, progesterone receptor, C-peptide, 25-OH-VD, CALP, anti-thyroid peroxidase, FSH, L. pn, and CA125.

The company's portfolio includes Class A and IVD General devices listed in the EUDAMED registry, and they are based in China.

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

Frequently asked questions

What does Hangzhou Realy Tech Co.,Ltd. manufacture?

Where is Hangzhou Realy Tech Co.,Ltd. based?

Hangzhou Realy Tech Co.,Ltd. is based in China, as indicated by the country code CN in their device data.

Which regulatory registries list Hangzhou Realy Tech Co.,Ltd.'s devices?

The company's devices are listed in the EUDAMED registry, which is the European database for medical devices, as specified in their device data.

How are Hangzhou Realy Tech Co.,Ltd.'s devices classified?

The company's devices are classified as Class A and IVD General, which are lower-risk categories in the regulatory classification system for medical devices.

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

Information

Country: China
Address: #2 Building, No. 763, Yuansha Village, Xinjie Street, Xiaoshan District, Hangzhou，Zhejiang, China
Website: www.realytech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-571-5605 0794
PRRC Contact: Bin Wu
EUDAMED SRN: CN-MF-000004716
FDA FEI Number: —
DUNS Number: —

Catalogue (120)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Squamous Cell Carcinoma Antigen (SCCA) Assay Reagent Kit	C2KA012	EUDAMED	IVD General	Active
Parathyroid Hormone(PTH) Assay Reagent Kit(CMIA)	C2KH002	EUDAMED	IVD General	Active
D-Dimer Rapid Test Device (Colloidal Gold)	B011016D	EUDAMED	IVD General	Active
Serum Amyloid A (SAA) Assay Reagent Kit (CMIA)	C2KF003	EUDAMED	IVD General	Active
The Drug Rapid Test (Urine)	/	EUDAMED	IVD General	Active
2019-nCoV-IgG Assay Reagent Kit (CMIA)	C2KJ011	EUDAMED	IVD General	Active
The B-type Natriuretic Peptide (BNP) Assay Reagent Kit (CMIA)	C2KE008	EUDAMED	IVD General	Active
Carbohydrate antigen 242 Assay Reagent Kit (CMIA)	C2KA018	EUDAMED	IVD General	Active
Methylene dioxy methamphetamine (MDMA) Assay Reagent Kit (CMIA)	C2KN009	EUDAMED	IVD General	Active
Typhoid IgG/IgM Rapid Test	K370216T	EUDAMED	IVD General	Active
2-IN-1 COVID-19 Antigen Rapid Test Device (swab)	K791416D	EUDAMED	IVD General	Active
The Drug Rapid Test (Saliva)	/	EUDAMED	IVD General	Active
Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA)	C2KL011	EUDAMED	IVD General	Active
Mycoplasma pneumoniae IgM antibody Assay Reagent Kit (CMIA)	C2KJ015	EUDAMED	IVD General	Active
2-IN-1 COVID-19 Antigen Rapid Test Device（Nasal&Saliva）	K711616D	EUDAMED	IVD General	Active
One Step Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test(Oral Fluid)	K740516D	EUDAMED	IVD General	Active
Carbohydrate Antigen 15-3 (CA15-3) Assay Reagent Kit (CMIA)	C2KA002	EUDAMED	IVD General	Active
Pregnancy Associated Plasma Protein A (PAPP-A) Assay Reagent Kit (CMIA)	C2KC011	EUDAMED	IVD General	Active
Carbohydrate antigen 50 Assay Reagent Kit (CMIA)	C2KA017	EUDAMED	IVD General	Active
Cortisol (Cor) Assay Reagent Kit (CMIA)	C2KC009	EUDAMED	IVD General	Active
Human Epididymis Protein 4 (HE4) Assay Reagent Kit (CMIA)	C2KA006	EUDAMED	IVD General	Active
Herpes Simplex Virus -Ⅰ/Ⅱ IgM (HSV-Ⅰ/Ⅱ IgM) Assay Reagent Kit (CMIA)	C2KL010	EUDAMED	IVD General	Active
Microalbumin (MALB) Assay Reagent Kit (CMIA)	C2KG004	EUDAMED	IVD General	Active
Cocaine（COC）Assay Reagent Kit (CMIA)	C2KN010	EUDAMED	IVD General	Active
Methamphetamines (MET) Assay Reagent Kit (CMIA)	C2KN001	EUDAMED	IVD General	Active
SARS-Cov-2＆ FLU A&B & RSV & Adv Combo Rapid Test Cassette (swab)	K551416D	EUDAMED	IVD General	Active
Opiates (OPI) Assay Reagent Kit (CMIA)	C2KN003	EUDAMED	IVD General	Active
Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)	C2KJ003	EUDAMED	IVD General	Active
Novel Coronavirus Neutralizing Antibody Assay Reagent Kit	C2KJ013	EUDAMED	IVD General	Active
2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma)	K460216D	EUDAMED	IVD General	Active
Methcathinone (CATH) Assay Reagent Kit (CMIA)	C2KN007	EUDAMED	IVD General	Active
Alpha-fetoprotein (AFP) Assay Reagent Kit (CMIA)	C2KA001	EUDAMED	IVD General	Active
Buprenorph (BUP) Assay Reagent Kit (CMIA)	C2KN008	EUDAMED	IVD General	Active
The VB12 Rapid Test	M010201T	EUDAMED	IVD General	Active
Pro-Gastrin Releasing Peptide (ProGRP) Assay Reagent Kit (CMIA)	C2KA013	EUDAMED	IVD General	Active
Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA)	C2KJ001	EUDAMED	IVD General	Active
Beta-2 Microglobulin (β2-MG) Assay Reagent Kit (CMIA)	C2KA014	EUDAMED	IVD General	Active
Dehydroepiandrosterone Sulfate (DHEA-S) Assay Reagent Kit (CMIA)	C2KC014	EUDAMED	IVD General	Active
NT-proBNP Rapid Test Device(Colloidal Gold)	E010116D	EUDAMED	IVD General	Active
Myeloperoxidase (MPO) Assay Reagent Kit (CMIA)	C2KE006	EUDAMED	IVD General	Active
HPV IgM Rapid Test Device	K410216D	EUDAMED	IVD General	Active
Carcinoembryonic Antigen (CEA) Assay Reagent Kit (CMIA)	C2KA005	EUDAMED	IVD General	Active
Influenza A&B Rapid Test	K251316T	EUDAMED	IVD General	Active
Unconjugated Estriol (uE3) Assay Reagent Kit (CMIA)	C2KC013	EUDAMED	IVD General	Active
Malaria P.f./P.v. Rapid Test Device	K280916D	EUDAMED	IVD General	Active
2019-nCOV-IgM Assay Reagent Kit (CMIA)	C2KJ012	EUDAMED	IVD General	Active
Fully Automatic Chemiluminescence Immunoassay Analyzer	RL-C4000	EUDAMED	Class A	Active
HbA1c Assay Reagent Kit (CMIA)	C2KG001	EUDAMED	IVD General	Active
Tissue polypeptide antigen(TPA) Assay Reagent Kit (CMIA)	C2KA023	EUDAMED	IVD General	Active
Marijuana (THC) Assay Reagent Kit (CMIA)	C2KN002	EUDAMED	IVD General	Active

Hangzhou Realy Tech Co.,Ltd.

What Hangzhou Realy Tech Co.,Ltd. makes

Frequently asked questions

Information

Catalogue (120)

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