Manufacturer's Devices - Assure Tech. (Hangzhou) Co. Ltd.

Address:




Building 4 No 1418-50 Moganshan Road Gongshu District



Zheijiang

Hangzhou 310011

China


Authorised Representative/ UK Responsible Person
Name: Medimap Ltd
Address:

2 The Drift



Thurston

Suffolk IP31 3RT

United Kingdom




Code/Term Type
HIV1/HIV2 antibody IVD kit rapid ICT clinicalHIV1/HIV2 antibody IVD kit rapid ICT clinicalIVD Annex II List A
Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Monkeypox virus antigen IVD kit rapid ICT clinicalMonkeypox virus antigen IVD kit rapid ICT clinicalIVD General
Morphine/morphine metabolite IVD kit rapid ICT clinicalMorphine/morphine metabolite IVD kit rapid ICT clinicalIVD General
Tricyclic antidepressant IVD kit rapid ICT clinicalTricyclic antidepressant IVD kit rapid ICT clinicalIVD General
Amphetamine/methamphetamine group IVD kit rapid ICT clinicalAmphetamine/methamphetamine group IVD kit rapid ICT clinicalIVD General
Acetaminophen IVD kit rapid ICT clinicalAcetaminophen IVD kit rapid ICT clinicalIVD General
Clonazepam IVD reagentClonazepam IVD reagentIVD General
Cotinine IVD kit rapid ICT clinicalCotinine IVD kit rapid ICT clinicalIVD General
Ethyl glucuronide (EtG) IVD reagentEthyl glucuronide (EtG) IVD reagentIVD General
2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD reagent2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD reagentIVD General
Monkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinicalMonkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinicalIVD General
Tramadol IVD kit rapid ICT clinicalTramadol IVD kit rapid ICT clinicalIVD General
Pregabalin IVD kit rapid ICT clinicalPregabalin IVD kit rapid ICT clinicalIVD General
Follicle stimulating hormone (FSH) IVD kit rapid ICT self-testingFollicle stimulating hormone (FSH) IVD kit rapid ICT self-testingIVD Devices for Self-Testing
Faecal occult blood IVD kit rapid ICT clinicalFaecal occult blood IVD kit rapid ICT clinicalIVD Devices for Self-Testing
Vaginal pH screening IVD kit rapid colorimetric self-testingVaginal pH screening IVD kit rapid colorimetric self-testingIVD Devices for Self-Testing
Glucose/ketone/lipid monitoring system IVD home-useGlucose/ketone/lipid monitoring system IVD home-useIVD Devices for Self-Testing
Glucose monitoring system IVD home-useGlucose monitoring system IVD home-useIVD Devices for Self-Testing
Total prostate specific antigen (tPSA) IVD kit rapid ICT clinicalTotal prostate specific antigen (tPSA) IVD kit rapid ICT clinicalIVD Annex II List B
Chlamydia trachomatis antigen IVD kit rapid ICT clinicalChlamydia trachomatis antigen IVD kit rapid ICT clinicalIVD Annex II List B
Multiple drugs of abuse IVD kit rapid ICT clinicalMultiple drugs of abuse IVD kit rapid ICT clinicalIVD General
Barbiturate IVD kit rapid ICT clinicalBarbiturate IVD kit rapid ICT clinicalIVD General
Cannabinoid/cannabinoid metabolite IVD kit rapid ICT clinicalCannabinoid/cannabinoid metabolite IVD kit rapid ICT clinicalIVD General
Propoxyphene/propoxyphene metabolite IVD kit rapid ICT clinicalPropoxyphene/propoxyphene metabolite IVD kit rapid ICT clinicalIVD General
Phencyclidine (PCP) IVD kit rapid ICT clinicalPhencyclidine (PCP) IVD kit rapid ICT clinicalIVD General
Opiate/opiate metabolite IVD kit rapid ICT clinicalOpiate/opiate metabolite IVD kit rapid ICT clinicalIVD General
Methadone IVD kit rapid ICT clinicalMethadone IVD kit rapid ICT clinicalIVD General
Methamphetamine-specific IVD kit rapid ICT clinicalMethamphetamine-specific IVD kit rapid ICT clinicalIVD General
6-Acetyl morphine IVD kit rapid ICT clinical6-Acetyl morphine IVD kit rapid ICT clinicalIVD General
Ketamine/ketamine metabolite IVD reagentKetamine/ketamine metabolite IVD reagentIVD General
Cocaine/cocaine metabolite IVD kit rapid ICT clinicalCocaine/cocaine metabolite IVD kit rapid ICT clinicalIVD General
Amphetamine-specific IVD kit rapid ICT clinicalAmphetamine-specific IVD kit rapid ICT clinicalIVD General
Benzodiazepine group IVD kit rapid ICT clinicalBenzodiazepine group IVD kit rapid ICT clinicalIVD General
Buprenorphine IVD kit rapid ICT clinicalBuprenorphine IVD kit rapid ICT clinicalIVD General
Oxycodone IVD kit rapid ICT clinicalOxycodone IVD kit rapid ICT clinicalIVD General
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD kit rapid ICT clinicalSynthetic cannabinoid/synthetic cannabinoid metabolite IVD kit rapid ICT clinicalIVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalRespiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Multiple alcohol IVD kit rapid ICT clinicalMultiple alcohol IVD kit rapid ICT clinicalIVD General
Troponin I IVD kit fluorescent immunoassayTroponin I IVD kit fluorescent immunoassayIVD General
Follicle stimulating hormone (FSH) IVD kit chemiluminescent immunoassayFollicle stimulating hormone (FSH) IVD kit chemiluminescent immunoassayIVD General
Myoglobin IVD kit fluorescent immunoassayMyoglobin IVD kit fluorescent immunoassayIVD General
D-dimer IVD kit fluorescent immunoassayD-dimer IVD kit fluorescent immunoassayIVD General
C-reactive protein (CRP) IVD kit fluorescent immunoassayC-reactive protein (CRP) IVD kit fluorescent immunoassayIVD General
Total triiodothyronine (TT3) IVD kit fluorescent immunoassayTotal triiodothyronine (TT3) IVD kit fluorescent immunoassayIVD General
Estradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassayEstradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassayIVD General
Prolactin IVD kit fluorescent immunoassayProlactin IVD kit fluorescent immunoassayIVD General
Procalcitonin (PCT) IVD kit fluorescent immunoassayProcalcitonin (PCT) IVD kit fluorescent immunoassayIVD General
Luteinizing hormone (LH) IVD kit rapid ICT clinicalLuteinizing hormone (LH) IVD kit rapid ICT clinicalIVD Devices for Self-Testing
Albumin IVD kit fluorescent immunoassayAlbumin IVD kit fluorescent immunoassayIVD General
Vitamin B12 IVD kit chemiluminescent immunoassayVitamin B12 IVD kit chemiluminescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinicalCarcinoembryonic antigen (CEA) IVD kit rapid ICT clinicalIVD General
Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayThyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayIVD General
Interleukin-6 (IL-6) IVD reagentInterleukin-6 (IL-6) IVD reagentIVD General
Serum amyloid A IVD reagentSerum amyloid A IVD reagentIVD General
Glycated haemoglobin (HbA1c) IVD reagentGlycated haemoglobin (HbA1c) IVD reagentIVD General
Cystatin C IVD reagentCystatin C IVD reagentIVD General
Multiple cardiac marker IVD kit fluorescent immunoassayMultiple cardiac marker IVD kit fluorescent immunoassayIVD General
Norovirus antigen IVD kit rapid ICT clinicalNorovirus antigen IVD kit rapid ICT clinicalIVD General
Free triiodothyronine (FT3) IVD kit chemiluminescent immunoassayFree triiodothyronine (FT3) IVD kit chemiluminescent immunoassayIVD General
Ferritin IVD kit fluorescent immunoassayFerritin IVD kit fluorescent immunoassayIVD General
Free thyroxine (FT4) IVD kit fluorescent immunoassayFree thyroxine (FT4) IVD kit fluorescent immunoassayIVD General
Human astrovirus antigen IVD kit rapid ICT clinicalHuman astrovirus antigen IVD kit rapid ICT clinicalIVD General
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD Devices for Self-Testing
Clostridium difficile antigen IVD kit rapid ICT clinicalClostridium difficile antigen IVD kit rapid ICT clinicalIVD General