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FOB Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TFO-R602Q(ACRO)Y2
Basic UDI-DI: B-TFO-R602Q(ACRO)Y2
Reference: TFO-R602Q
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OVDA-ACOR402QYZ
Basic UDI-DI: B-OVDA-ACOR402QYZ
Reference: OVDA-ACOR402Q
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OVD-R402(ACRO)FA
Basic UDI-DI: B-OVD-R402(ACRO)FA
Reference: OVD-R402
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Rapid Test Cassette

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OHA-R402(ACRO)RS
Basic UDI-DI: B-OHA-R402(ACRO)RS
Reference: OHA-R402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution

VGC02

IVD generalIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211293
Basic UDI-DI: B-06937339211293
Reference: VGC02-0Y1
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.08.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strip

VGS02

IVD generalIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211286
Basic UDI-DI: B-06937339211286
Reference: VGS02-0Y2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.08.2026 06:39

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Blood Glucose Test Strip

VGS02

IVD generalIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211279
Basic UDI-DI: B-06937339211279
Reference: VGS02-0Y1
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.08.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strip

VGS02

IVD generalIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211262
Basic UDI-DI: B-06937339211262
Reference: VGS02-0Y3
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.08.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

URINE STRIPS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G45852801100HN
Basic UDI-DI: B-G45852801100HN
Reference: 528 01 100
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 11.08.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-CN-MF-000027592TG

JZ-11A, IS-11L，IS-10L，JZ-14A,JZ-10A, JZ-10M,URS-10T,JZ-3P,JZ-2G，URIC-10CF,URIC-3V,URIC-2GP，URS-11V

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Jinzhun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000027592
UDI-DI: D-CN-MF-000027592TG
Basic UDI-DI: B-CN-MF-000027592TG
Reference: W0101060204
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.08.2026 23:29

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D-697566851GLUTEST01HC76

Blood glucose Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Jinzhun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000027592
UDI-DI: D-697566851GLUTEST01HC76
Basic UDI-DI: B-697566851GLUTEST01HC76
Reference: W0101060101
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.08.2026 23:28

Manufacturer products Authorised representative products Authorised representative actors View details

Reagent Strips for Urinalysis

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Jinzhun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000027592
UDI-DI: 06975668510007
Basic UDI-DI: 697566851URINESTRIP01VB
Reference: W0101060204
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 10.08.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983107976
Basic UDI-DI: B-06936983107976
Reference: TFO-602H
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Slovakia
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.08.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

Zinc Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-HZN-ACO001C3
Basic UDI-DI: B-HZN-ACO001C3
Reference: HZN-ACO001
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

1drop™ TBIL

B20

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: 08800075500380
Basic UDI-DI: B-08800075500380
Reference: B20290
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

1drop™ Glucose

G18

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: D-G18190WQ
Basic UDI-DI: B-G18190WQ
Reference: G18190
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

1drop™ TBIL

B20

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: D-B2019015TWG
Basic UDI-DI: B-B2019015TWG
Reference: B2019015T
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

1drop™ AST

O19

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: 08800075500373
Basic UDI-DI: B-08800075500373
Reference: O19290
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

1drop™ ALT

P19

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: D-P191902P
Basic UDI-DI: B-P191902P
Reference: P19190
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

1drop™ TC

C18

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: 08800075500342
Basic UDI-DI: B-08800075500342
Reference: C18290
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details