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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

18.09.2026 01:51

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160 device results listed.

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Progesterone (P4) Test Cassette

Progesterone (P4) Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrP4402FLV
Basic UDI-DI: B-acrP4402FLV
Reference: acrP4402F
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1/fFN Combo Test Cassette

iGFBP-1/fFN Combo Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrGFN502F2Q
Basic UDI-DI: B-acrGFN502F2Q
Reference: acrGFN502F
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test Dipstick

iGFBP-1 Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FIG-501(ACRO)WA
Basic UDI-DI: B-FIG-501(ACRO)WA
Reference: FIG-501
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnanediol-3-Glucuronide (PDG) Test Cassette

Pregnanediol-3-Glucuronide (PDG) Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrPDG102F3E
Basic UDI-DI: B-acrPDG102F3E
Reference: acrPDG102F
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Estrone-3-glucuronide (E3G) Test Cassette

Estrone-3-glucuronide (E3G) Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrE3G102FNY
Basic UDI-DI: B-acrE3G102FNY
Reference: acrE3G102F
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroglobulin (TG) Test Cassette

Thyroglobulin (TG) Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-TG-402Q9
Basic UDI-DI: B-ACO-TG-402Q9
Reference: ACO-TG-402
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

hGH Test Cassette

hGH Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-HGH-402L6
Basic UDI-DI: B-ACO-HGH-402L6
Reference: ACO-HGH-402
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

SP-10 Male Fertility Rapid Test Cassette

SP-10 Male Fertility Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OSP-R902RP
Basic UDI-DI: B-OSP-R902RP
Reference: OSP-R902
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Rapid Test Cassette

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OTS-R402Q(ACRO)EW
Basic UDI-DI: B-OTS-R402Q(ACRO)EW
Reference: OTS-R402Q
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Placental alpha Microglobulin-1 (PAMG-1) Rapid Test

Placental alpha Microglobulin-1 (PAMG-1) Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FPAM-ACO5022M
Basic UDI-DI: B-FPAM-ACO5022M
Reference: FPAM-ACO502
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Rapid Test Cassette

AMH Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FAMH-R402QXA
Basic UDI-DI: B-FAMH-R402QXA
Reference: FAMH-R402Q
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

Maybe Baby

IVD self-testing devicesIVDDOn the marketSelf testing

Manufacturer: OPTIX DOO BEOGRAD-ZEMUN
Manufacturer SRN: RS-MF-000031651
UDI-DI: 09317039000460
Basic UDI-DI: B-09317039000460
Reference: MB 00.00.00
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Northern Ireland
Authorised representative: Salus Cons Kft.
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Rapid Quantitative Test

AMH Rapid Quantitative Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208586
Basic UDI-DI: 69332602IF0100044ZW
Reference: BT0208801
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Fibronectin Rapid Test

WFFN9001 WFFN9002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-WFFN9005G
Basic UDI-DI: B-WFFN9005G
Reference: WFFN9001 WFFN9002
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sperm SP10 Protein Rapid Test

WSPEf002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-WSPEf00JB
Basic UDI-DI: B-WSPEf00JB
Reference: WSPEf002
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 08:11

Manufacturer products Authorised representative products Authorised representative actors View details

Test de Grossesse Sanguin

Test de Grossesse Sanguin

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077402397
Basic UDI-DI: B-03701077402397
Reference: NGB-HCG-W23-028
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:05

Manufacturer products View details

NG-TEST® HCG Whole Blood

NG-TEST® HCG Whole Blood

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077401420
Basic UDI-DI: B-03701077401420
Reference: VIB-HCG-W21-003
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:05

Manufacturer products View details

NG-TEST® HCG Whole Blood

NG-TEST® HCG Whole Blood

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077400720
Basic UDI-DI: B-03701077400720
Reference: NGB-HCG-W23-001
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:05

Manufacturer products View details

NG-TEST® hCG Blood Precision

NG-TEST® hCG Blood Precision

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077400669
Basic UDI-DI: B-03701077400669
Reference: NGB-HCG-W23-023
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:05

Manufacturer products View details

NG-TEST® HCG Whole Blood

NG-TEST® HCG Whole Blood

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077400157
Basic UDI-DI: B-03701077400157
Reference: VIB-HCG-W21-001
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:05

Manufacturer products View details