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25-OH-VD Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490404
Basic UDI-DI: B-06975679490404
Reference: HU-RE-F08F027002
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983169905
Basic UDI-DI: B-06936983169905
Reference: OVD-402H
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 10.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858885
Basic UDI-DI: B-06933289858885
Reference: WA26P0006
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858878
Basic UDI-DI: B-06933289858878
Reference: WA26P0005
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858861
Basic UDI-DI: B-06933289858861
Reference: WA26P0004
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858854
Basic UDI-DI: B-06933289858854
Reference: WA26P0003
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858564
Basic UDI-DI: B-06933289858564
Reference: WA05P0004
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858557
Basic UDI-DI: B-06933289858557
Reference: WA05P0003
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858540
Basic UDI-DI: B-06933289858540
Reference: WA05P0002
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858533
Basic UDI-DI: B-06933289858533
Reference: WA05P0001
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858151
Basic UDI-DI: B-06933289858151
Reference: W492P0005
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858144
Basic UDI-DI: B-06933289858144
Reference: W492P0004
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858137
Basic UDI-DI: B-06933289858137
Reference: W492P0003
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858120
Basic UDI-DI: B-06933289858120
Reference: W492P0002
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Aldosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858588
Basic UDI-DI: B-06933289858588
Reference: WA06P0002
EMDN: W0102060201
EMDN description: ALDOSTERONE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 09.08.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208470
Basic UDI-DI: B-06933260208470
Reference: BT2301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218319

Glycosylated Hemoglobin A1c Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218319
Basic UDI-DI: B-06941967218319
Reference: 2013501
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 02:15

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (Electrochemiluminescence Immunoassay)

100T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680596
Basic UDI-DI: B-06970341680596
Reference: 689013
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D Total (Electrochemiluminescence Immunoassay)

100 T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680602
Basic UDI-DI: B-06970341680602
Reference: 693011
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

C-peptide (Electrochemiluminescence Immunoassay)

100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680619
Basic UDI-DI: B-06970341680619
Reference: 695011
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details