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978 device results listed.

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D-FHC-101KX

FHC-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-FHC-101KX
Basic UDI-DI: B-FHC-101KX
Reference: FHC-101
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Quantitative Test Kit (Time-Resolved FIA)

FAHCG-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAHCG-402aQ5
Basic UDI-DI: B-FAHCG-402aQ5
Reference: FAHCG-402a
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Quantitative Test Kit (Time-Resolved FIA)

FAHCG-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAHCG-402aHGKV
Basic UDI-DI: B-FAHCG-402aHGKV
Reference: FAHCG-402a
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy (hCG) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: D-F001-1001RH
Basic UDI-DI: B-F001-1001RH
Reference: F001-1001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 21:10

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

Easy @ Home Pregnancy Test

EZW1-S-5

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-S-5PM
Basic UDI-DI: B-EZW1-S-5PM
Reference: EZW1-S-5
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZW1-MN-5

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-MN-5FW
Basic UDI-DI: B-EZW1-MN-5FW
Reference: EZW1-MN-5
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZW1-MN-2

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-MN-2FQ
Basic UDI-DI: B-EZW1-MN-2FQ
Reference: EZW1-MN-2
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZM1-H3

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZM1-H3YP
Basic UDI-DI: B-EZM1-H3YP
Reference: EZM1-H3
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNM0000180726001MY

Cassette, Strip, Midstream, Urine Cup

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180726001MY
Basic UDI-DI: B-CNM0000180726001MY
Reference: 6001C 6001S 6001D 6001B
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Romania
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Pregnancy Test 2in1

Strip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: D-ACK21001-S02-018AS
Basic UDI-DI: B-ACK21001-S02-018AS
Reference: ACK21001-S02-018
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Pregnancy Test Comfort

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: D-ACK21001-M01-01879
Basic UDI-DI: B-ACK21001-M01-01879
Reference: ACK21001-M01-018
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Pregnancy Test

Cassette

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Core Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023522
UDI-DI: D-ACK21001-C01-018ZU
Basic UDI-DI: B-ACK21001-C01-018ZU
Reference: ACK21001-C01-018
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Pregnancy Test

Midstream

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-C123
Basic UDI-DI: B-ABT-FT-C123
Reference: ABT-FT-C1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HCG Multi-Line Midstream (Urine)

Midstream

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-C387PM
Basic UDI-DI: B-ABT-FT-C387PM
Reference: ABT-FT-C387
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Pregnancy Test

Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-B1ZV
Basic UDI-DI: B-ABT-FT-B1ZV
Reference: ABT-FT-B1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HCG Multi-Line Strip (Urine)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-A387P7
Basic UDI-DI: B-ABT-FT-A387P7
Reference: ABT-FT-A387
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step HCG Pregnancy Test

Strip

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-FT-A1ZS
Basic UDI-DI: B-ABT-FT-A1ZS
Reference: ABT-FT-A1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Digital Pregnancy Rapid Test

DC811

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testingSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: D-8595566428563GB
Basic UDI-DI: B-8595566428563GB
Reference: 0811S7X001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 10:19

Manufacturer products Authorised representative products Authorised representative actors View details

Simple hCG s&o / Stick hCG s&o

9.005.XXX.YY.ZZZ

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779005XKH9
Basic UDI-DI: B-84295779005XKH9
Reference: 9.005.XXX.YY.ZZZ
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details