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227 device results listed.

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Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190701
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402H-01
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

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

Fecal Occult Blood Rapid Test Device (Feces)

GEFB-606b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFB-606bHGGL
Basic UDI-DI: B-GEFB-606bHGGL
Reference: GEFB-606b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-A054D6

INDICAID™ Fecal Occult Blood (FOB) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A054D6
Basic UDI-DI: B-A054D6
Reference: INDICAID™ Fecal Occult Blood (FOB) Rapid Test
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-84352873423U4AF

Fecal Occult Blood cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: D-84352873423U4AF
Basic UDI-DI: B-84352873423U4AF
Reference: 4325225
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:40

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Cromatest

Fecal Occult Blood cassette

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873423007
Basic UDI-DI: B-84352873423007
Reference: 4325225
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:34

Manufacturer products View details

Alpha Fetal Protein FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646AFP001FJB3E
Basic UDI-DI: B-697424646AFP001FJB3E
Reference: AFP-3012F
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha Fetal Protein FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646AFP000FJ82M
Basic UDI-DI: B-697424646AFP000FJ82M
Reference: AFP-4012F
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

FOB-F21(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-697177120111587
Basic UDI-DI: B-697177120111587
Reference: FOB-U21(25PCS)
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB)Test

FOB strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990606QH
Basic UDI-DI: B-693757990606QH
Reference: FOB strip cassette
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Fecal Occult Blood Test Card

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-69219637108198R
Basic UDI-DI: B-69219637108198R
Reference: 1M01C4
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

One-Step Immunological Transferrin Test

cassette; strip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-6909620WHSTF97DD
Basic UDI-DI: B-6909620WHSTF97DD
Reference: WH-FOB-S0x0201; WH-FOB-S0x0202
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

One-step Immunological Hemoglobin and Transferrin Test

strip; Cassette

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-6909620WHSFOBTFLHR2
Basic UDI-DI: B-6909620WHSFOBTFLHR2
Reference: WH-FOB-S0x0401; WH-FOB-S0x0402
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Actim Combi® Hemoglobin Transferrin

30322ETAC

IVD generalIVDDNo longer on the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990639UJ
Basic UDI-DI: B-6430030990639UJ
Reference: 30322ETAC
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:43

Manufacturer products View details

Actim® Fecal Blood Buffer

30372ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990042T9
Basic UDI-DI: B-6430030990042T9
Reference: 30372ETAC
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Actim® Fecal Blood dipsticks

30361ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990028TF
Basic UDI-DI: B-6430030990028TF
Reference: 30361ETAC
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Actim® Fecal Blood

30331ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990011SW
Basic UDI-DI: B-6430030990011SW
Reference: 30331ETAC
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Cancer Embryo Antigen Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5C02C1UY
Basic UDI-DI: B-5C02C1UY
Reference: 5C02C1-25-EU, 5C02C1-50-EU
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5C01C1UT
Basic UDI-DI: B-5C01C1UT
Reference: 5C01C1-25-EU, 5C01C1-50-EU
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251876
Basic UDI-DI: B-06976232251876
Reference: CA05-07-422P25
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251869
Basic UDI-DI: B-06976232251869
Reference: CA05-02-422P25
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details