GenSure Biotech Inc. devices, product family

by GenSure Biotech Inc. 24 variants Basic UDI-DI 697683823P201600ES

Shared by every variant

Manufacturer: GenSure Biotech Inc.(24)
Basic UDI-DI: 697683823P201600ES
Risk class: Class B
Legislation: IVDR
EMDN category: HCG - RT & POC
Market status: 24 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 697683823P201600ES.

Certificates

1 certificate naming this Basic UDI-DI · EUDAMED

V76 126886 0004 Technical documentation · refdata.applicable-legislation.ivdr issued
Notified body 0123 · holder GenSure Biotech Inc. · issued 16 Jul 2025 · expires 15 Jul 2030

Recalls

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 24 devices listed on this page; other pages of the family can carry others.

Variants

24 devices · page 1 of 1

Variants of GenSure Biotech Inc. devices, Basic UDI-DI 697683823P201600ES
		UDI-DI	Size and differences
DIAGOTEC HCG Pregnancy Rapid Test	P2016M01 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	06976838234839	—	On the market
DIAGOTEC SZYBKI TEST CIĄŻOWY HCG	P2016M01 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	06976838234617	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016C03 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235079	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016C05 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235086	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016C25 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235093	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016M01 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235017	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016M02 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235024	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016M03 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235031	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016M05 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235048	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016M25 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235055	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016S10 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235116	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016S25 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235123	—	On the market
EuroGen HCG Pregnancy Rapid Test	Y2016S50 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838235130	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016C03 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230081	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016C05 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230098	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016C25 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230104	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016M01 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230029	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016M02 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230036	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016M03 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230043	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016M05 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230050	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016M25 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230067	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016S10 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230128	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016S25 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230135	—	On the market
GenSure HCG Pregnancy Rapid Test	P2016S50 / P2016C03, P2016C05, P2016C25, P2016M01, P2016M02, P2016M03, P2016M05, P2016M25, P2016S10, P2016S25, P2016S50; Y2016C03, Y2016C05, Y2016C25, Y2016M01, Y2016M02, Y2016M03, Y2016M05, Y2016M25, Y2016S10, Y2016S25, Y2016S50	16976838230142	—	On the market