Assure Tech. (Hangzhou) Co., Ltd. devices, product family

by Assure Tech. (Hangzhou) Co., Ltd.and 1 other manufacturer record 10 variants Basic UDI-DI 69528048GOP-101PROSK85

Shared by every variant

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.(5)Assure Tech. (Hangzhou) Co., Ltd.(5)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI: 69528048GOP-101PROSK85
Risk class: Class C
Legislation: IVDR
EMDN category: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER BLOOD GLUCOSE METERS BLOOD TEST STRIPS CONTROLS
Market status: 10 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 69528048GOP-101PROSK85.

1 certificate naming this Basic UDI-DI · EUDAMED

IX 2074650-2 Technical documentation · refdata.applicable-legislation.ivdr issued
Notified body 0197 · holder Assure Tech. (Hangzhou) Co., Ltd. · issued 17 Mar 2026 · expires 16 Mar 2031

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 10 devices listed on this page; other pages of the family can carry others.

10 devices · page 1 of 1

Variants of Assure Tech. (Hangzhou) Co., Ltd. devices, Basic UDI-DI 69528048GOP-101PROSK85
		UDI-DI	Size and differences
AcuteckTM Blood Glucose Control Solution Assure Tech. (Hangzhou) Co., Ltd.	C901095	06952804819880	—	On the market
AcuteckTM Blood Glucose Monitoring System Assure Tech. (Hangzhou) Co., Ltd.	GOP-101ProSK	06952804819446	—	On the market
AcuteckTM Blood Glucose Test Meter Assure Tech. (Hangzhou) Co., Ltd.	GOH-101	06952804828288	—	On the market
AcuteckTM Blood Glucose Test Meter Assure Tech. (Hangzhou) Co., Ltd.	GOH-101Pro	06952804823313	—	On the market
AcuteckTM Blood Glucose Test Strips Assure Tech. (Hangzhou) Co., Ltd.	C901005-05	06952804819958	—	On the market
AcuteckTM Blood Glucose Test Strips Assure Tech. (Hangzhou) Co., Ltd.	C901005-10	06952804823344	—	On the market
AcuteckTM Blood Glucose Test Strips Assure Tech. (Hangzhou) Co., Ltd.	C901005-100	06952804819453	—	On the market
AcuteckTM Blood Glucose Test Strips Assure Tech. (Hangzhou) Co., Ltd.	C901005-25	06952804823351	—	On the market
AcuteckTM Blood Glucose Test Strips Assure Tech. (Hangzhou) Co., Ltd.	C901005-50	06952804823368	—	On the market
AcuteckTMBlood Glucose Test Meter Assure Tech. (Hangzhou) Co., Ltd.	GOH-201	06952804828295	—	On the market