Manufacturer

Bitrumed

ChinaLegal entities : Bi-trumed Biotech Co., Ltd.

Markets : Germany

EU representative : VidaQuick Biotech S.L. (Spain)

info@bitrumed.com.cn

18 categories, 140 models including 140 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Bacteriology - RT & POC - other	W0105090199	Brucella Abortus Ag Test98/79 Campylobacter Test CAM-6C198/79 Candida albicans Test CA-5C198/79 Cryptococcus Ag Test CRY-4C198/79 Gonorrhea Test98/79 29 others H. pylori Ag Test HP-6A198/79 H. pylori Ag Test HP-6C198/79 H. pylori Ag Test HP-6F198/79 H. pylori Antibody Rapid Test Cassette IHP-30298/79 H. pylori Antibody Rapid Test Cassette IHP-40298/79 H. pylori Antibody Test HP-3C198/79 H. pylori Antibody Test HP-4A198/79 H. pylori Antibody Test HP-4C198/79 H.pylori Antigen Rapid Test Cassette IHP-60298/79 Leptospira IgG/IgM Test LEP-4C198/79 Lyme IgG/IgM Test LY-4C198/79 Mycoplasma pneumoniae Ag Test MP-5C198/79 Mycoplasma Pneumoniae Antigen Rapid Test Cassette IMP-50298/79 Mycoplasma Pneumoniae IgG/IgM Combo Test MPB-4C298/79 Mycoplasma pneumoniae IgM Rapid Test Cassette IMPM-40298/79 Mycoplasma Pneumoniae IgM Test MPM-4C198/79 Salmonella paratyphi Ag Test98/79 Salmonella typhi & paratyphi Ag Test98/79 Salmonella typhi Ag Test98/79 Scrub Typhus IgG/IgM Test98/79 Shigella Test SH-6C298/79 Streptococcus pneumoniae & Legionella pneumophila Combo Test98/79 Tetanus Test TET-4C198/79 Trichomonas Vaginalis Test TV-5C198/79 Tuberculosis (TB) Test2 refs98/79 Typhoid IgG/IgM Test3 refs98/79 Vibrio cholerae O1/O139 Test98/79 Vibrio cholerae O1 (VC O1) Test98/79 Vibrio cholerae O139 (VC O139) Test98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Adenovirus Antigen Rapid Test Cassette IAD-50298/79 Adenovirus pneumoniae Ag Test ADE-5C198/79 Adenovirus Rapid Test Cassette IAD-60298/79 Adenovirus Test ADE-6C198/79 Adenovirus Test ADE-6F198/79 21 others Astrovirus Test AST-6C198/79 Astrovirus Test AST-6F198/79 Chikungunya IgG/IgM Test CHI-3C198/79 Chikungunya IgG/IgM Test CHI-4C198/79 Dengue IgG/IgM Test DEN-4C198/79 Dengue IgG/IgM & NS1 Combo Test98/79 Dengue NS1 Test98/79 HAV IgG/IgM Test HAVB-4C298/79 HAV IgM Test HAVM-4C198/79 HEV IgG/IgM Test HEV-3C198/79 HMPV Test98/79 HPIV Test98/79 HPV Ag Test HPV-5C198/79 Norovirus Test NOR-6C198/79 Norovirus Test NOR-6F198/79 Rotavirus Rapid Test Cassette IRO-60298/79 Rotavirus Test ROT-6C198/79 Rotavirus Test ROT-6F198/79 Zika IgG/IgM & NS1 Test98/79 Zika IgG/IgM Test ZIB-4C198/79 Zika NS1 Test98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Adenovirus &RSV Combo Test AR-5C298/79 Adenovirus, RSV & Flu A+B Combo Test98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Ag Combo Test98/79 Dengue/Chikungunya/Zika Combo Test DCZ-4C398/79 Dengue/Zika/Chikungunya Combo Test DZC-4C498/79 15 others HSV 1/2 IgG Test2 refs98/79 HSV 1/2 IgG/IgM Test4 refs98/79 HSV 1/2 IgM Test2 refs98/79 Norovirus, Rotavirus & Adenovirus Test NRA-6C298/79 Norovirus, Rotavirus & Adenovirus Test NRA-6F298/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6C398/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6F498/79 Rotavirus & Adenovirus Test RA-6C198/79 Rotavirus & Adenovirus Test RA-6F198/79 Rotavirus and Adenovirus Combo Rapid Test Cassette IRAC-62598/79 RSV&Flu A+B Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Test98/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Chagas Test CHA-3C198/79 Chagas Test CHA-4C198/79 Cryptosporidium & Giardia Lamblia Combo Test CG-6C298/79 Cryptosporidium Test CRY-6C198/79 Entamoeba histolytica Test EH-6C198/79 5 others Entamoeba/Giardia/Crypto Combo Test2 refs98/79 Entamoeba/Giardia/Crypto Test98/79 Filariasis IgG/IgM Test2 refs98/79 Giardia Lamblia Test GL-6C198/79 Leishmania IgG/IgM Test LEI-4C198/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6C398/79 Clostridium difficile GDH & Toxin A &Toxin B Combo Test CD-6F398/79 Clostridium difficile GDH Rapid Test Cassette ICDG-60298/79 Clostridium difficile GDH Test CDG-6C198/79 Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette ICD-635B98/79 2 others Clostridium difficile Toxin A &Toxin B Combo Test CDT-6C298/79 Clostridium difficile Toxin A + Toxin B Combo Rapid Test Cassette ICDT-625B98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Flu A Test2 refs98/79 Flu A+B Test2 refs98/79 Flu A/B & H1N1 Combo Test98/79 H1N1 Test98/79 Influenza A+B Rapid Test Cassette IIN-50298/79 1 other Influenza A+B Rapid Test Dipstick98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f. Test MAL-4A198/79 Malaria P.f. Test MAL-4C198/79 Malaria P.f./ P.v. /Pan Test MPVF-4C198/79 Malaria P.f./ P.v. Test MPV-4C198/79 Malaria P.f./ Pan Test MPN-4C198/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Rapid Test Cassette IST-50298/79 Strep A Test STA-5A198/79 Strep A Test STA-5C198/79 Strep A Test STAB-5A198/79 Strep A Test STAB-5C198/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	SARS-CoV-2 IgG Test2 refs98/79 SARS-CoV-2 IgG/IgM Test2 refs98/79 SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 S-RBD IgG Antibody Test98/79	– 98/79	EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC	W0105099003	EBNA IgG Test ENG-4C198/79 EBV VCA & EBNA IgG Combo Test ECN-4C298/79 EBV VCA IgG Test ECG-4C198/79 MONO Test MONO-4C198/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Test SYP-3A198/79 Syphilis Test SYP-3C198/79 Syphilis Test SYP-4A198/79 Syphilis Test SYP-4C198/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Ag Test3 refs98/79 SARS-CoV-2 Ag Test (Nasal Swab)98/79 SARS-CoV-2 Ag Test (Oral fluid)2 refs98/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Rapid Test Cassette ISB-50298/79 Strep B Test STB-5A198/79 Strep B Test STB-5C198/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	SARS-CoV-2 & Flu A+B Ag Combo Test2 refs98/79 SARS-CoV-2/Flu A+B/RSV Ag Combo Test98/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella pneumophila Rapid Test Cassette98/79 Legionella pneumophila Test98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Rapid Test Cassette IRS-50298/79 RSV Test RSV-5C198/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	S. pneumoniae Antigen Rapid Test Cassette ISP-10298/79 Streptococcus pneumoniae Ag Test98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Virus Antibody Test MXB-4C198/79	– 98/79	EUDAMED record Report an error

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