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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 Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984061986
Basic UDI-DI: 6970341680320200102JF
Reference: 0320200201
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
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

MR Serum Standard

105-001689-00、105-001690-00、105-001691-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026497
Basic UDI-DI: 69449040BA80MRISE******JW
Reference: 105-001689-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

UIBC Calibrator

105-009265-00、105-004515-00、105-004516-00、105-002306-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031521
Basic UDI-DI: 69449040004JUIBC*******XA
Reference: 105-002306-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Pancreatic Amylase Calibrator

please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053115339
Basic UDI-DI: 69449040AB710000547
Reference: 105-053163-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

β-HB Calibrator

105-006184-00、105-004513-00、105-004514-00、105-002319-00、105-002320-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032375
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-002319-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Multi Sera Calibrator

105-001144-00

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026046
Basic UDI-DI: 694490400046MultiCal***XZ
Reference: 105-001144-00
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Lipids Calibrator

105-001128-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025889
Basic UDI-DI: 694490400046LipidsCal**VP
Reference: 105-001128-00
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Abtrol

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153810442
Basic UDI-DI: 6438153BU00044BM
Reference: 981044
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 18:02

Manufacturer products View details

Nortrol

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153810435
Basic UDI-DI: 6438153BU00045BP
Reference: 981043
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 18:02

Manufacturer products 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

ALDOLASE AND GLUTATHIONE REDUCTASE LEVEL 2 CONTROL (ALS & GLUT RED CONTROL 2)

ALDOLASE AND GLUTATHIONE REDUCTASE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218848
Basic UDI-DI: 50552732BAGRCON157B9
Reference: AGR10572
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS & GLUT RED CAL)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218831
Basic UDI-DI: 50552732BAGRCAL1565X
Reference: AGR10571
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +)

XANTHOCHROMIA CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218725
Basic UDI-DI: 50552732BXTHPON1553F
Reference: XN10505
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

SERUM INDICES (SERUM INDICES)

SERUM INDICES

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217025
Basic UDI-DI: 50552732BSEMDCE128EF
Reference: SI10448
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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

Liquid Immunoassay Control - Level 1 (IA CONTROL 1)

Liquid Immunoassay Control

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273210101
Basic UDI-DI: 50552732BLIACON169BJ
Reference: LIA5142
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
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

sLDL CALIBRATOR (sLDL CAL)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273208436
Basic UDI-DI: 50552732BSLDLCR100K8
Reference: CH5050
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details