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GlucoDr.One™ Control Solution

AGM-4200

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128342006
Basic UDI-DI: 88061283AGM4200CE6
Reference: AGM-4200-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G03-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.auto™ A Blood Glucose Test Strip

AGM-4000

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128340125
Basic UDI-DI: 88061283AGM4000SEQ
Reference: AGM-4000-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G10-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.auto™ A Control Solution

AGM-4000

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128340101
Basic UDI-DI: 88061283AGM4000CDQ
Reference: AGM-4000-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G10-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.SuperSensor™ Blood Glucose Test Strip

AGM-2200

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128320042
Basic UDI-DI: 88061283AGM2200SEG
Reference: AGM-2200-S1-P4
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G02-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.SuperSensor™ Control Solution

AGM-2200

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128320004
Basic UDI-DI: 88061283AGM2200CDG
Reference: AGM-2200-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G02-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.™ Blood Glucose Test Strip

AGM-2100

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128310524
Basic UDI-DI: 88061283AGM2100SE9
Reference: AGM-2100-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G01-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.™ Control Solution

AGM-2100

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128310500
Basic UDI-DI: 88061283AGM2100CD9
Reference: AGM-2100-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G01-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

Pine Smart Baby Diaper

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingSingle use

Manufacturer: Arkan Grup Sağlık Ürünleri A.Ş.
Manufacturer SRN: TR-MF-000027138
UDI-DI: 08699096963676
Basic UDI-DI: 869909696PS9Y
Reference: PSMN.02-R-24
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:31

Manufacturer products View details

CH Reaktif Prob Temizleyici 1 (RPC1)

CH Reaktif ProbTemizleyici1 (RPC1)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812530521
Basic UDI-DI: 86818125HD001JH
Reference: AT5001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:22

Manufacturer products View details

Urinalysis Strips

100 strips/bottle×10 + 1 IC card (FUS-10)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794573640
Basic UDI-DI: B-16925794573640
Reference: 231050101006
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Washing solution PS-200 (10 x 10 mL)

IVD Class ANot specifiedOn the market

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155006234
Basic UDI-DI: 8430155SOLUCIONLAVADOFK
Reference: 999950
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:33

Manufacturer products View details

I.S.E. / TARGA washing solution (10 x 10mL)

I.S.E. / TARGA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155002427
Basic UDI-DI: 8430155KITISEVV
Reference: 990815
EMDN: W0101070304
EMDN description: COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:32

Manufacturer products View details

Bisulfite Conversion Kit (Magnetic Beads)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SINGLERA GENOMICS (JIANGSU) LTD.
Manufacturer SRN: CN-MF-000033428
UDI-DI: 16975970650283
Basic UDI-DI: 697597065EP20CENX
Reference: EP200192CE
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

Bisulfite Conversion Kit (Magnetic Beads)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SINGLERA GENOMICS (JIANGSU) LTD.
Manufacturer SRN: CN-MF-000033428
UDI-DI: 16975970650276
Basic UDI-DI: 697597065EP20CENX
Reference: EP200048CE
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Cuvette Wash Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066774002
Basic UDI-DI: 697806677OT002QM
Reference: 7600-PA00003
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

06977805760245

General

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760245
Basic UDI-DI: 697780576HSTAALIBMG6J
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

06977805760214

AA05-01-24S

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760214
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218869

Focusing Fluid

IVD Class AIVDR 2017/746On the marketAnimal tissuesReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218869
Basic UDI-DI: 69732628600303ZT
Reference: 01.09.1F.01.09.03
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Morphology Quality Control

3.0mL/bottle×5, 2.0mL/bottle×10, 4.0mL/bottle×2,2.0mL/bottle×5,

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522648964
Basic UDI-DI: 697052264SJPOZ0008VP
Reference: BB1600
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 31.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control Material

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062044
Basic UDI-DI: 6970341680320200101JD
Reference: 0320200301
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details