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06952804819262

Strip

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819262
Basic UDI-DI: B-06952804819262
Reference: C906005
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.09.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

06952804819217

Strip

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819217
Basic UDI-DI: B-06952804819217
Reference: C903005
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.09.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors View details

06952804832919

Device

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804832919
Basic UDI-DI: 69528048A4387102X
Reference: A43871125
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fastep Male Fertility (SP-10) Home Test

Device

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804830809
Basic UDI-DI: 69528048A06610H2B
Reference: A06610H21
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

06952804835064

CS-S01，CS-S02

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835064
Basic UDI-DI: 69528048CS-S01MK
Reference: CS-S01
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 16:43

Manufacturer products Authorised representative products Authorised representative actors View details

AcuteckTM Blood Glucose Test Strips

Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819491
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: C902005-100
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Monitoring System

Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819446
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: GOP-101ProSK
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 07:12

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Meter

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804823313
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: GOH-101Pro
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Meter

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804828288
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: GOH-101
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTMBlood Glucose Test Meter

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804828295
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: GOH-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Strips

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819958
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: C901005-05
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Control Solution

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819880
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: C901095
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819507
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: GHP-101ProSK
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Strips

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819965
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: C902005-05
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Control Solution

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819897
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: C902095
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Strips

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804823375
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: C902005-10
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Strips

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804823382
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: C902005-25
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Strips

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804823399
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: C902005-50
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Strips

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804823344
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: C901005-10
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

AcuteckTM Blood Glucose Test Strips

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804823351
Basic UDI-DI: 69528048GOP-101ProSK85
Reference: C901005-25
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): TH-R025-9.1 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details