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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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INNODX AMH CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-AMH-01100CQ8
Basic UDI-DI: B-KR-AMH-01100CQ8
Reference: KR-AMH-01100C
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX AFP CMIA

KR-AFP-01100C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-AFP-01100CPX
Basic UDI-DI: B-KR-AFP-01100CPX
Reference: KR-AFP-01100C
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB1219D

Cholinesterase Kit (Standard Method/DGKC 94’)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB1219D
Basic UDI-DI: B-KHB1219D
Reference: /
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB1209B

Inorganic Phosphorous Kit (UV Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB1209B
Basic UDI-DI: B-KHB1209B
Reference: /
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB1159J

α-Amylase Kit (CNPG3 Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB1159J
Basic UDI-DI: B-KHB1159J
Reference: /
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB1119A

Lactate Dehydrogenase Kit (Lactate Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB1119A
Basic UDI-DI: B-KHB1119A
Reference: /
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB1099P

Total Bile Acids Kit (Enzyme Cycling Method)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB1099P
Basic UDI-DI: B-KHB1099P
Reference: /
EMDN: W01010202
EMDN description: BILE ACIDS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB1089M

Creatine Kinase-MB Isoenzyme Kit (Immunoinhibition Method)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB1089M
Basic UDI-DI: B-KHB1089M
Reference: /
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB10197

Apolipoprotein A1 Kit (Immunoturbidimetric Assay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB10197
Basic UDI-DI: B-KHB10197
Reference: /
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB1059F

Low Density Lipoprotein Cholesterol Kit (Enzyme Clearance Assay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB1059F
Basic UDI-DI: B-KHB1059F
Reference: /
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-KHB10299

Apolipoprotein B Kit (Immunoturbidimetric Assay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-KHB10299
Basic UDI-DI: B-KHB10299
Reference: /
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck TSH

TSH Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K42-TSHK9
Basic UDI-DI: B-K42-TSHK9
Reference: K42-TSH
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

InfectCheck PCT

PCT Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K12-PCTGN
Basic UDI-DI: B-K12-PCTGN
Reference: K12-PCT
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

InfectCheck NeoPT (quantitative)

NeoPT Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K12-NEOG8
Basic UDI-DI: B-K12-NEOG8
Reference: K12-NEO
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

InfectCheck CRP

CRP Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K12-CRPFS
Basic UDI-DI: B-K12-CRPFS
Reference: K12-CRP
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Methcathinone Test Strip (Urine)

GBMTC-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBMTC-101aHG32
Basic UDI-DI: B-GBMTC-101aHG32
Reference: GBMTC-101a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home Ovulation Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-EZW2-SKG
Basic UDI-DI: B-EZW2-SKG
Reference: EZW2-S
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home Pregnancy Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-EZW1-SKB
Basic UDI-DI: B-EZW1-SKB
Reference: EZW1-S
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-CH-MF-000034473JT

800060-x

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-CH-MF-000034473JT
Basic UDI-DI: B-CH-MF-000034473JT
Reference: 800060-x
EMDN: W01021111
EMDN description: ANTI-STREPTOCOCCAL SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 13.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB Plus

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: D-8908007989460CA
Basic UDI-DI: B-8908007989460CA
Reference: 601130005, 601130020, 601130025, 601130050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details