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Teste Rápido de Gravidez (Pantest HCG Rapid Test)

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: Pantest SA
Manufacturer SRN: PT-MF-000026431
UDI-DI: 05600233273001
Basic UDI-DI: B-05600233273001
Reference: hCg03
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Portugal
Authorised representative: -
Last updated: 02.08.2026 21:51

Manufacturer products View details

Sainsbury's Health Matters 2 Pregnancy

Sainbury's Pregnancy Midstream Twin

IVD self-testing devicesIVDDOn the marketNo EU repAnimal tissuesReagentSelf testingSingle use

Manufacturer: CIGA Healthcare Ltd
Manufacturer SRN: XI-MF-000025280
UDI-DI: 05060100939513
Basic UDI-DI: B-05060100939513
Reference: 00188
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.08.2026 17:49

Manufacturer products View details

Eveline Ovulation Test

WHM-A01

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: iXensor Co., Ltd.
Manufacturer SRN: TW-MF-000026279
UDI-DI: 04719872951971
Basic UDI-DI: B-04719872951971
Reference: WHM-A01
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Eveline Ovulation Test Kit

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: iXensor Co., Ltd.
Manufacturer SRN: TW-MF-000026279
UDI-DI: 04719872951964
Basic UDI-DI: B-04719872951964
Reference: 1964
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Eveline Ovulation Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: iXensor Co., Ltd.
Manufacturer SRN: TW-MF-000026279
UDI-DI: 04719872951889
Basic UDI-DI: B-04719872951889
Reference: 1889
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

PHRONESIA Smart Ovulation Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: iXensor Co., Ltd.
Manufacturer SRN: TW-MF-000026279
UDI-DI: 04719872951872
Basic UDI-DI: B-04719872951872
Reference: 1872
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Eveline Ovulation Test Kit

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: iXensor Co., Ltd.
Manufacturer SRN: TW-MF-000026279
UDI-DI: 04719872951629
Basic UDI-DI: B-04719872951629
Reference: 1629
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Hungary
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

TestPack Plus hCG Urine with OBC

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesNear-patient testingProfessional testingSingle use

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226471807
Basic UDI-DI: B-04571226471807
Reference: 505798J
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

Easy@Home 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: 00810038637884
Basic UDI-DI: B-00810038637884
Reference: 0811S7X002
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:30

Manufacturer products Authorised representative products Authorised representative actors View details

PRIMA HOME TEST

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164861524
Basic UDI-DI: 764016486HGEH8B6
Reference: HGEH88B00KIT02HU
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

SANAVITA TEST Gravidanza - EARLY DETECTION PREGNANCY TEST

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164861661
Basic UDI-DI: 764016486HGEH8B6
Reference: HGEH8SV00KIT01IT
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

femSense

Class IMDR 2017/745On the marketActive deviceDirect markingSingle use

Manufacturer: SteadySense GmbH
Manufacturer SRN: AT-MF-000003984
UDI-DI: 09120095900052
Basic UDI-DI: 912009590FEM012L
Reference: 09120095900052
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:39

Manufacturer products View details

OvuFind

OVFRPD-01 OVFRPD-02

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006721
Basic UDI-DI: 8905459OVULHRDTSFA5
Reference: OVFRPD-01 OVFRPD-02
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Laboquick

LBOV.01

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Manufacturer SRN: TR-MF-000032257
UDI-DI: 08699195610297
Basic UDI-DI: 8699195610LBOV.015Q
Reference: LBOV.01
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:41

Manufacturer products View details

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IVD rapid tests

IVD Class BIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012974
Basic UDI-DI: 5944759012SEENOWDMIVD00EC
Reference: SN1.1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:18

Manufacturer products View details

Ultra Early Pregnancy Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216339773
Basic UDI-DI: 4084500CB14QT
Reference: 08700216339773
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Ultra Early Pregnancy Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216483681
Basic UDI-DI: 4084500CB14QT
Reference: 08700216483681
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrarani test za trudnoću

CB14

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08001841567471
Basic UDI-DI: 4084500CB14QT
Reference: 08001841567471
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

Test shtatzënie me zbulim të shpejtë

CB11/CB11A

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500759572
Basic UDI-DI: 4084500CB11/CB11AUR
Reference: 04084500759572
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy testing kit-(7.0mm)

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Nantong Diagnos Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000041526
UDI-DI: 06934592100081
Basic UDI-DI: B-06934592100081
Reference: AE68
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details