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596 device results listed.

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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

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857956
Basic UDI-DI: B-06933289857956
Reference: W393P0007
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
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

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857949
Basic UDI-DI: B-06933289857949
Reference: W393P0006
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
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

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857932
Basic UDI-DI: B-06933289857932
Reference: W393P0005
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
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

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857925
Basic UDI-DI: B-06933289857925
Reference: W393P0004
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
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

FinecareTM

W207-C7PM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289801249
Basic UDI-DI: 69332898CE0124EK
Reference: W207-C7PM
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CSD-W207(2)-06 · Rev. 01
Authorised representative: QbD RepS BV
Last updated: 09.08.2026 23:23

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

FinecareTM

Finecare CRP Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289801232
Basic UDI-DI: 69332898CE0123EH
Reference: W201P0011
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CSD-W201(2)-01-06 · Rev. 01
Authorised representative: QbD RepS BV
Last updated: 09.08.2026 23:23

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

FinecareTM

W201P0010

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289801225
Basic UDI-DI: 69332898CE0122EF
Reference: W201P0010
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CSD-W201(2)-01-06 · Rev. 01
Authorised representative: QbD RepS BV
Last updated: 09.08.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED 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

SmarLumi

Central Nervous System Specific Protein S100β (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858328
Basic UDI-DI: B-06933289858328
Reference: W498P0001
EMDN: W01021702
EMDN description: PROTEIN S-100 B
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

U-Card™ 200

Lower Respiratory Pathogen Panel Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849968
Basic UDI-DI: B-06933289849968
Reference: WR40P0004
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

Respiratory Pathogen Panel Test(B)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853941
Basic UDI-DI: B-06933289853941
Reference: WR94P0002
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

Respiratory Pathogen Panel Test(B)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853934
Basic UDI-DI: B-06933289853934
Reference: WR94P0001
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

C.difficile Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853927
Basic UDI-DI: B-06933289853927
Reference: WR89P0003
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

C.difficile Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853910
Basic UDI-DI: B-06933289853910
Reference: WR89P0002
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

C.difficile Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853903
Basic UDI-DI: B-06933289853903
Reference: WR89P0001
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289854030
Basic UDI-DI: B-06933289854030
Reference: WR90P0002
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details