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562 device results listed.

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00817238010042

91474

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Cliniqa Corporation
Manufacturer SRN: US-MF-000023908
UDI-DI: 00817238010042
Basic UDI-DI: B-00817238010042
Reference: 91474
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Austria
Authorised representative: CEpartner4U
Last updated: 01.08.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Agamatrix Control Solution Normal

800003550

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: AgaMatrix, Inc.
Manufacturer SRN: US-MF-000039145
UDI-DI: 00385540355002
Basic UDI-DI: B-00385540355002
Reference: 80003550
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Northern Ireland
Authorised representative: MDSS GmbH
Last updated: 01.08.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoDr.PRO™ BLE Control Solution

ABM-514P

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351404
Basic UDI-DI: 88061283ABM514PCF6
Reference: ABM-514P-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G05-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

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

GlucoDr.PRO™ Control Solution

AGM-514P

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351305
Basic UDI-DI: 88061283AGM514PCHT
Reference: AGM-514P-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G07-06 · Rev. 02
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

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

GlucoDr.S™ BLE Control Solution

ABM-513S

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350605
Basic UDI-DI: 88061283ABM513SCFA
Reference: ABM-513S-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G11-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

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

GlucoDr.S™ Control Solution

AGM-513S

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350407
Basic UDI-DI: 88061283AGM513SCHX
Reference: AGM-513S-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G06-06 · 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.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 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™ 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.™ 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

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

URINE LOW OSMOLALITY CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220377
Basic UDI-DI: 50552732BLOOSMC160RD
Reference: UC10650
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:14

Manufacturer products View details

CUSTOM LIQUID URINE CONTROL - LEVEL 1

CUSTOM LIQUID URINE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214802
Basic UDI-DI: 50552732BLUCN121507N
Reference: UC5170
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

sLDL CONTROL LEVEL 1 (sLDL CONTROL 1)

sLDL CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209075
Basic UDI-DI: 50552732BSLDLCL099K6
Reference: LE5013
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)

LIPID CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204155
Basic UDI-DI: 50552732BLPDCON080GR
Reference: LE2661
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

CSF CONTROL - LEVEL 2 (CSF CONTROL 2)

CSF CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273201116
Basic UDI-DI: 50552732BCSFCON038D6
Reference: CF1500
EMDN: W0101050208
EMDN description: CSF CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2)

ALDOLASE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273200096
Basic UDI-DI: 50552732BALSCON005DZ
Reference: AD5001
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

small dense LDL-Control Set

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503563088
Basic UDI-DI: 4987503sdLDLconPA
Reference: 08834105190
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

trister® Control Solution

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128310609
Basic UDI-DI: 88061283AGM2100CD9
Reference: AGM-2100-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G01-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

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

G1 Advance Control Solution

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128340408
Basic UDI-DI: 88061283AGM4000CDQ
Reference: AGM-4000-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G10-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

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