Manufacturer

Safecare

ChinaLegal entities : SAFECARE BIOTECH (HANGZHOU) CO., LTD.

Markets : Germany · Greece · Spain · United States

Approvals : United States (FDA) – 510(k) : 9 · class I, II · latest in 2025 · see on the FDA website

EU representative : UnicareQ GmbH (Germany)

16 categories, 114 models including 114 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
Virology - RT & POC - other	W0105099099	Adenovirus Antigen Rapid Test (Feces) ADV-5011/ADV-501298/79 Adenovirus Rapid Test (Feces) ADV-5011/ADV-501298/79 Chikungunya IgG/IgM Rapid Test(Serum/Plasma) CHIK-302298/79 Chikungunya IgG/IgM Rapid Test(Whole Blood/Serum/Plasma) CHIK-402298/79 Hantavirus IgG/IgM Rapid Test(WB/S/P)98/79 14 others Hantavirus Rapid Test(WB/S/P)98/79 Herpes simplex virus Rapid Test (Whole Blood/Serum/Plasma) HSV-402298/79 Herpes simplex virus(HSV) IgG/IgM Rapid Test (Serum/Plasma) HSV-302298/79 Herpes simplex virus(HSV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) HSV-402298/79 Norovirus Antigen FIA Test (Feces)98/79 Rotavirus-Adenovirus Combo Rapid Test Kit(Feces) ROT-502298/79 Rotavirus-Adenovirus Combo Rapid Test (Feces) ROT-502298/79 Rotavirus-Adenovirus-Astrovirus Combo Rapid Test (Feces) MID-5032b98/79 Rotavirus-Adenovirus-Norovirus Combo Rapid Test (Feces) MID-5032a98/79 Rotavirus-Adenovirus-Norovirus-Astrovirus Combo Rapid Test(Feces) MID-504298/79 Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma)98/79 Rubella.Virus(RV) IgM/IgG Test(Whole Blood/Serum/Plasma)98/79 Zika IgM/IgG Rapid Test(Serum/Plasma) ZIKA-302298/79 Zika IgM/IgG Rapid Test(Whole Blood/Serum/Plasma) ZIKA-402298/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Brucella IgG/IgM Rapid Test (Serum/Plasma) Bru-302298/79 Brucella IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) BRU-402298/79 Brucella IgG/IgM Rapid Test(WB/S/P)98/79 Cholera O1 Antigen Rapid Test98/79 Cholera O1 Antigen Rapid Test(Feces)98/79 11 others Gonorrhoea Rapid Test Kit(Swab)98/79 Gonorrhoea Rapid Test(Swab)98/79 Legionella & S.pneumoniae Antigen Combo Rapid Test(Urine) MID-102298/79 S.Typhi Antigen Rapid Test (Feces)98/79 S.Typhi(TYP) Antigen Rapid Test (Feces)98/79 Tuberculosis Rapid Test (Serum/Plasma)98/79 Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)98/79 Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma)98/79 Typhoid IgG/IgM Rapid Test (Serum/Plasma)98/79 Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 Typhoid IgG/IgM Rapid Test Kit (Whole Blood/serum/plasma)98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Bacterial Vaginosis Multi-Test Kit98/79 Bacterial Vaginosis Multi-Test(Swab)98/79 COVID-19/Flu/RSV/ADV/hMPV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 7 others COVID-19/FluA&B/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Kit98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Serum/Plasma)98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Whole Blood/Serum/Plasma)98/79 Prueba rápida combinada de antígenos de COVID-19/Gripe/VSR (Hisopo)98/79 Respiratory Pathogens Antigen Combo Rapid Test MID-614298/79 ViraxClear Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) COVID-19/Flu A&B/RSV/ADV Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma) CTNI-401298/79 Dengue IgG/IgM Rapid Test (Serum/Plasma) DEN-302298/79 Dengue IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) DEN-402298/79 Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma) DEN-302298/79 Dengue IgG/IgM/NS1 Combo Rapid Test (WB/S/P)98/79 5 others Dengue IgG/IgM/NS1 Combo Rapid Test (Whole Blood/Serum/Plasma)98/79 Dengue IgG/IgM/NS1 Combo Rapid Test(Serum/Plasma)98/79 Dengue NS1 Rapid Test (Serum/Plasma)98/79 Dengue NS1 Rapid Test (Whole Blood/Serum/Plasma)98/79 Dengue NS1 Rapid Test Kit(Whole Blood/serum/plasma)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f. Rapid Test (Whole Blood) MAL-4011a/MAL-4012a98/79 Malaria P.v. Rapid Test (Whole Blood) MAL-4011b/MAL-4012b98/79 Malaria P.f. Rapid Test Kit(Whole Blood) MAL-4011/MAL-4012a98/79 Malaria P.f./P.v. Rapid Test Kit(Whole Blood) MAL-4022a98/79 Malaria P.f./P.v. Rapid Test (Whole Blood) MAL-4022a98/79 4 others Malaria P.f./Pan Rapid Test Kit(Whole Blood) MAL-4022b98/79 Malaria P.f./Pan Rapid Test (Whole Blood) MAL-4022b98/79 Malaria P.v./Pan Rapid Test (Whole Blood) MAL-4022c98/79 Malaria Pan Rapid Test (Whole Blood) MAL-4011c/MAL-4012c98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	COVID-19 & Influenza A+B Antigen Combo Rapid Test98/79 Kit de prueba de antígenos de múltiples virus respiratorios ( Hisopo ) (Gripe A+B/ COVID-19)98/79 Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)98/79 Multi-Respiratory Virus Antigen Test(Swab) (Influenza A+B/ COVID-19)98/79 Prueba Rápida Combinada de Antígenos de COVID-19 y Gripe A+B98/79 1 other Συνδυαστικό τεστ ταχείας ανίχνευσης αντιγόνου του COVID-19 και της Ινφλουέντζας A+B Για αυτοδοκιμή COVID-19 & Influenza A+B Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)" HPAb-4011/HPAb-401298/79 H.pylori Antibodies Rapid Test (Serum/Plasma) HPAb-3011/HPAb-301298/79 H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma) HPAb-4011/HPAb-401298/79 H.pylori Antigen FIA Test (Feces)98/79 H.pylori Antigen Rapid Test (Feces) HPAg-5011/HPAg-501298/79 1 other H.pylori Antigen Rapid Test Kit(Feces) HPAg-5011/HPAg-501298/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Virus Antigen Rapid Test98/79 Monkeypox Virus Antigen Rapid Test(Serum/Plasma) MON Ag-301298/79 Monkeypox Virus Antigen Rapid Test(Swab) MON Ag-601298/79 Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma) MON Ag-401298/79 Monkeypox Virus IgG/IgM Rapid Test(Serum/Plasma) MON Ab-302298/79 1 other Monkeypox Virus IgG/IgM Rapid Test(Whole blood/Serum/Plasma) MON Ab-402298/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Chagas Rapid Test (Serum/Plasma) CHA-3011/CHA-301298/79 Chagas Rapid Test (WB/S/P)98/79 Chagas Rapid Test (Whole Blood/Serum/Plasma) CHA-4011/CHA-401298/79 Leishmaniasis IgG/IgM Rapid Test (Serum/Plasma)98/79 Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 1 other Leishmaniasis Rapid Test (Whole Blood/serum/plasma)98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID-19 Antigen FIA Test (Swab)98/79 COVID-19 Antigen Rapid Test Kit (Swab)98/79 COVID-19 IgG/IgM FIA Test (Serum/Plasma)98/79 COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)98/79 Kit de Detección Rápida de Antígenos de COVID-19 (Hisopo)-Nasal98/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	Hepatitis A Virus Rapid Test (Whole Blood/Serum/Plasma)98/79 Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Serum/Plasma) HAV-302298/79 Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) HAV-402298/79 Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma) HAV-301298/79 Hepatitis A Virus(HAV) IgM Rapid Test (Whole Blood/Serum/Plasma) HAV-401298/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Rotavirus Antigen Rapid Test(Feces) ROT-5011/ROT-501298/79 Rotavirus Rapid Test (Feces) ROT-5011/ROT-501298/79 Strep B Rapid Test (Swab) STB-6011/STB-601298/79 Strep B Rapid Test Kit (swab) STB-6011/STB-601298/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Antigen FIA Test (Swab)98/79 RSV Antigen Rapid Test RSV-6011/ RSV-601298/79 RSV Antigen Rapid Test(Swab) RSV-6011/RSV-601298/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Test (Serum/Plasma) SYP-3011/SYP-401198/79 Syphilis Rapid Test (Whole Blood/Serum/Plasma) SYP-4011/SYP-401298/79 Syphilis Rapid Test Kit(Whole Blood/serum/plasma)98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B Antigen FIA Test (Swab)98/79 Influenza A/B Antigen Rapid Test（Swab） FLU-602298/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Rapid Test (Swab) STA-6011/STA-601298/79 Strep A Rapid Test Kit (swab) STA-6011/STA-601298/79	– 98/79	EUDAMED record Report an error

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