Fabricant

Safecare

ChineEntités : SAFECARE BIOTECH (HANGZHOU) CO., LTD.

Premiers pays de mise sur le marché déclarés dans EUDAMED : Allemagne, Espagne, Grèce

Mandataire UE : UnicareQ GmbH (Allemagne)

16 catégories, 114 modèles dont 114 en vente, 1 pays

En vente
Plus commercialisé
93/42 Ancienne directive, pas encore certifié selon le règlement MDR
Cliquez sur une catégorie pour voir les concurrents, sur un modèle pour ouvrir sa fiche EUDAMED.

Catégorie	Code EMDN	Modèles enregistrés	Classe	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 autres 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	Fiche EUDAMED Signaler une erreur
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 autres 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	Fiche EUDAMED Signaler une erreur
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 autres 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	Fiche EUDAMED Signaler une erreur
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 autres 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	Fiche EUDAMED Signaler une erreur
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 autres 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	Fiche EUDAMED Signaler une erreur
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 autre 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	Fiche EUDAMED Signaler une erreur
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 autre H.pylori Antigen Rapid Test Kit(Feces) HPAg-5011/HPAg-501298/79	– 98/79	Fiche EUDAMED Signaler une erreur
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 autre Monkeypox Virus IgG/IgM Rapid Test(Whole blood/Serum/Plasma) MON Ab-402298/79	– 98/79	Fiche EUDAMED Signaler une erreur
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 autre Leishmaniasis Rapid Test (Whole Blood/serum/plasma)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur

Un modèle enregistré dans EUDAMED n'est pas forcément commercialisé dans votre pays. Vérifiez la disponibilité et le marquage CE auprès du fabricant.

Vous n'avez pas trouvé ?

Décrivez ce que vous cherchez. Les demandes nous indiquent quelles catégories ajouter en priorité.