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InTec PRODUCTS, INC.

China·CN-MF-000023625

Last updated September 18, 2026

About

FOUNDED IN 1989 AS A HIGH-TECH ENTERPRISE SPECIALIZED IN THE DEVELOPMENT, PRODUCTION AND MARKETING OF IN VITRO DIAGNOSTIC PRODUCTS. AS ONE OF THE OLDEST IVD ENTERPRISES IN THE COUNTRY, THE COMPANY RELIES ON THE DEPTH OF IMMUNOLOGICAL DETECTION TECHNIQUES FOR INFECTIOUS DISEASES, WHICH FORM THE CORE OF PACT AND ENZYMES, WITH A FOCUS ON THE DEVELOPMENT OF THE OPERATIONAL LAYOUT OF PRODUCTS SUCH AS BIOCHEMICAL, CHEMICAL LIGHTING AND MOLECULAR DIAGNOSTICS。

Translated from the manufacturer's own website. Source

What InTec PRODUCTS, INC. makes

The company manufactures rapid in vitro diagnostic (IVD) tests for drug detection and infectious disease screening. Its portfolio includes single-use lateral flow assays for substances like phencyclidine (PCP), buprenorphine, tramadol, and multi-analyte tests for drugs of abuse (DOA). It also produces point-of-care tests for respiratory pathogens, such as SARS-CoV-19 and influenza A, in both standalone and combined formats.

These devices fall under EU IVD Annex II List A and General classification categories, and they are registered in the EUDAMED database. The company is 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 types of medical devices does InTec PRODUCTS, INC. manufacture?

InTec PRODUCTS, INC. specializes in rapid in vitro diagnostic (IVD) tests. Their portfolio includes single-use lateral flow assays for detecting drugs of abuse (such as phencyclidine, buprenorphine, and tramadol) and multi-analyte tests for screening multiple substances simultaneously. Additionally, they produce point-of-care tests for infectious diseases, including standalone and combined formats for detecting SARS-CoV-19 and influenza A.

Where is InTec PRODUCTS, INC. based?

InTec PRODUCTS, INC. is based in China. The company’s headquarters and operations are located within the country, where it develops, produces, and markets its IVD products.

Which regulatory registries list InTec PRODUCTS, INC.’s devices?

InTec PRODUCTS, INC.’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This ensures transparency and traceability of their products under EU regulatory frameworks.

How are InTec PRODUCTS, INC.’s devices classified under EU regulations?

InTec PRODUCTS, INC.’s devices fall under EU IVD Annex II List A and General classification categories. Annex II List A applies to higher-risk IVDs (e.g., those detecting infectious agents or drugs of abuse), while General classification covers lower-risk devices. Classification determines regulatory requirements, such as conformity assessment procedures.

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

Information

Country
China
Address
332 Xinguang Road, Xinyang Industrial Area,Haicang, , Xiamen, China
LinkedIn
—
Facebook
—
Phone
+86 592 680 7228
PRRC Contact
Nicole Zhang
EUDAMED SRN
CN-MF-000023625
FDA FEI Number
—
DUNS Number
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Catalogue (84)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
ONE STEP Phencyclidine (PCP) Test ITP06009-DS50
EUDAMED
IVD GeneralActive
One Step Multi-7 DOA Test ITP06106-DT20
EUDAMED
IVD GeneralActive
ONE STEP Multi-8 DOA Test ITP06107-DT20
EUDAMED
IVD GeneralActive
ONE STEP Multi-4 DOA Test ITP06103-DT20
EUDAMED
IVD GeneralActive
ONE STEP Buprenorphine (BUP) Test ITP06013-DS50
EUDAMED
IVD GeneralActive
ONE STEP Tramadol (TRA) Test ITP06014-TC40
EUDAMED
IVD GeneralActive
ONE STEP Buprenorphine (BUP) Test ITP06013-TC40
EUDAMED
IVD GeneralActive
One Step Multi-7 DOA Test ITP06106-DT10
EUDAMED
IVD GeneralActive
AQ+Rapid SARS-CoV-19/ Flu Combo Test ITP16050-TC1
EUDAMED
IVD GeneralActive
Rapid Flu A Test ITP081001-TC20
EUDAMED
IVD GeneralActive
AQ+Rapid SARS-CoV-19/ Flu Combo Test ITP16050-TC25
EUDAMED
IVD GeneralActive
ONE STEP Multi-5 DOA Test ITP06104-DT20
EUDAMED
IVD GeneralActive
ONE STEP Ecstasy (MDMA) Test ITP06010-TC40
EUDAMED
IVD GeneralActive
ONE STEP Multi-8 DOA Test ITP06107-DT10
EUDAMED
IVD GeneralActive
Rapid Anti-HEV-IgM Test ITP091101-TC40
EUDAMED
IVD GeneralActive
ONE STEP Methamphetamine (MET) Test ITP06005-DS50
EUDAMED
IVD GeneralActive
ONE STEP Multi-9 DOA Test ITP06108-DT10
EUDAMED
IVD GeneralActive
ONE STEP Benzodiazepines (BZO) Test ITP06006-TC40
EUDAMED
IVD GeneralActive
ONE STEP Tramadol (TRA) Test ITP06014-DS50
EUDAMED
IVD GeneralActive
ONE STEP Cocaine (COC) Test ITP06004-TC40
EUDAMED
IVD GeneralActive
ONE STEP Opiate (OPI/Morphine) Test ITP06002-TC40
EUDAMED
IVD GeneralActive
ONE STEP Methadone (MTD) Test ITP06008-DS50
EUDAMED
IVD GeneralActive
ONE STEP Multi-11 DOA Test ITP06110-DT10
EUDAMED
IVD GeneralActive
Rapid Anti-H.Pylori Test ITP10002-TC40
EUDAMED
IVD GeneralActive
Rapid Rotavirus Test ITP14001-TC20
EUDAMED
IVD GeneralActive
ONE STEP Multi-3 DOA Test ITP06102-DT20
EUDAMED
IVD GeneralActive
ONE STEP Pregnancy (hCG) Test ITP04002-DS50
EUDAMED
IVD GeneralActive
69361558covid19-Ag-Be**x5 ITP16013-TC25-
EUDAMED
IVD GeneralActive
Rapid Anti-HEV-IgM Test ITP091101-DS50
EUDAMED
IVD GeneralActive
AQ+ COVID-19 Ag Rapid Test ITP16042-TC25-
EUDAMED
IVD GeneralActive
ONE STEP Cannabinoids (THC) Test ITP06003-DS50
EUDAMED
IVD GeneralActive
One Step Amphetamine (AMP) Test ITP06001-TC40
EUDAMED
IVD GeneralActive
ONE STEP Benzodiazepines (BZO) Test ITP06006-DS50
EUDAMED
IVD GeneralActive
ONE STEP Barbiturates (BAR) Test ITP06007-DS50
EUDAMED
IVD GeneralActive
Rapid Anti-H.Pylori Test ITP10212-DS50
EUDAMED
IVD GeneralActive
ONE STEP Malaria(p.f/p.v) Tri-line Test ITP11003-TC25
EUDAMED
IVD GeneralActive
ONE STEP Malaria(p.f.) Test ITP11002-TC25
EUDAMED
IVD GeneralActive
ONE STEP Multi-12 DOA Test ITP06111-DT10
EUDAMED
IVD GeneralActive
ONE STEP H. pylori Ag Test ITP10003-TC20
EUDAMED
IVD GeneralActive
ONE STEP Barbiturates (BAR) Test ITP06007-TC40
EUDAMED
IVD GeneralActive
AQ+ COVID-19 Ag Rapid Test ITP16042-TC25
EUDAMED
IVD GeneralActive
ONE STEP H. pylori Ag Test ITP10213-TC20
EUDAMED
IVD GeneralActive
AQ+ COVID-19 Ag Rapid Test ITP16044-TC25
EUDAMED
IVD GeneralActive
ONE STEP Opiate (OPI/Morphine) Test ITP06002-DS50
EUDAMED
IVD GeneralActive
W0105040601 ITP14002-TC20
EUDAMED
IVD GeneralActive
ONE STEP Multi-2 DOA Test ITP06101-DT20
EUDAMED
IVD GeneralActive
ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test ITP71002-DS50
EUDAMED
IVD GeneralActive
AQ+ COVID-19 Ag Rapid Test ITP16042-TC5
EUDAMED
IVD GeneralActive
ONE STEP Cannabinoids (THC) Test ITP06003-DS50
EUDAMED
IVD GeneralActive
COVID-19/FluA&B/RSV Ag Combo Rapid Test ITP182603-TC25
EUDAMED
IVD GeneralActive

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