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EUDAMED Device Search

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

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06.07.2026 20:24

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Active filter:Manufacturer SRN:US-MF-000009941

23 device results listed.

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OraQuick HIV Self-Test

1001-0629U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001686
Basic UDI-DI: B-00608337001686
Reference: 1001-0629U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Cyprus
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick TEST HIV PENTRU AUTOTESTARE

1001-0627U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001662
Basic UDI-DI: B-00608337001662
Reference: 1001-0627U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

AUTOTEST PER L’HIV OraQuick

1001-0603U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001532
Basic UDI-DI: B-00608337001532
Reference: 1001-0603U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

Test OraQuick NA OBECNOŚĆ WIRUSA HIV DO SAMODZIELNEGO WYKONANIA

1001-0628U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001679
Basic UDI-DI: B-00608337001679
Reference: 1001-0628U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0602U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001525
Basic UDI-DI: B-00608337001525
Reference: 1001-0602U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0601U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001518
Basic UDI-DI: B-00608337001518
Reference: 1001-0601U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0600U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001273
Basic UDI-DI: B-00608337001273
Reference: 1001-0600U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick SAMOTEST NA HIV

1001-0630U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001068
Basic UDI-DI: B-00608337001068
Reference: 1001-0630U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

3001-2141

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000566
Basic UDI-DI: B-00608337000566
Reference: 3001-2141
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick® HCV Rapid Antibody Test Kit Controls

1001-0278

IVD Annex II List AIVDDOn the marketHuman tissuesNear-patient testingProfessional testing

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000528
Basic UDI-DI: B-00608337000528
Reference: 1001-0278
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337000563
Basic UDI-DI: B-10608337000563
Reference: 1001-0274
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Intercept i2

IVD Class ANot specifiedNo longer on the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337000914
Basic UDI-DI: 0608337300126127F
Reference: 1001-0362
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick SAMOTEST NA HIV

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001065
Basic UDI-DI: B-10608337001065
Reference: 1001-0630
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001270
Basic UDI-DI: B-10608337001270
Reference: 1001-0600
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

AUTOTESTE DE VIH OraQuick

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001515
Basic UDI-DI: B-10608337001515
Reference: 1001-0601
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001522
Basic UDI-DI: B-10608337001522
Reference: 1001-0602
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

AUTOTEST PER L’HIV OraQuick

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001539
Basic UDI-DI: B-10608337001539
Reference: 1001-0603
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick TEST HIV PENTRU AUTOTESTARE

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001669
Basic UDI-DI: B-10608337001669
Reference: 1001-0627
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Test OraQuick NA OBECNOŚĆ WIRUSA HIV DO SAMODZIELNEGO WYKONANIA

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001676
Basic UDI-DI: B-10608337001676
Reference: 1001-0628
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

IVD Annex II List ANot specifiedOn the market

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001683
Basic UDI-DI: B-10608337001683
Reference: 1001-0629
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details