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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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OraSure Technologies, Inc. — Manufacturer in United States

EUDAMED update: Feb 27, 2025

OT

OraSure Technologies, Inc.

United States

All roles followed

Views by role

Sources: EUDAMED

Legal information of OraSure Technologies, Inc.

Legal name: OraSure Technologies, Inc.
EU VAT number: Not applicable
SRN (displayed role): US-MF-000009941
EUDAMED status: Active· registered in 2021
Registered office: East First Street, 220 18015 Bethlehem, United States

Contact details for OraSure Technologies, Inc.

Phone: +1 610-882-1820
Email: customercare@orasure.com
Website: www.orasure.com
Address: 220, EAST FIRST STREET 18015 BETHLEHEM UNITED STATES

Data export

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Medical device manufacturers in EUDAMED

Competent authority for OraSure Technologies, Inc.

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
BelgiumContact the authority →

Certificates of OraSure Technologies, Inc.

No certificates registered for this manufacturer.

20Total Devices

20Basic UDI-DIs

0Certificates0 valid · 0 expiring < 12 months

25CountriesEU/EEA placements

Executives & regulatory representatives of OraSure Technologies, Inc.

6 contacts identified

KRAUSE Jennifer
PRRC
View profile →
MILLER Tiffany
PRRC
View profile →
RADER Rebecca
PRRC
View profile →
MILLER Tiffany
MDR Article 15(3) & IVD Article 15(3)
Hidden
KRAUSE Jennifer
MDR Article 15(3) (a), (c), (d) & IVDR Article 15(3) (a), (c), (d)
Hidden
RADER Rebecca
MDR Article 15(3) & IVD Article 15(3)
Hidden

Market presence of OraSure Technologies, Inc.

Devices placed in 25 countries

Czechia6
Germany6
Spain6
France6
Greece6
Italy6
Poland6
Romania6
Slovakia6
Bulgaria5
Ireland5
Portugal5
Belgium4
Denmark4
Finland4
Croatia4
Iceland4
Lithuania4
Netherlands4
Norway4
Sweden4
Austria3
Estonia3
Hungary3
Cyprus2

Risk categories of OraSure Technologies, Inc.

Cartography of OraSure Technologies, Inc.

Authorised representativePeople

QbD RepS BV — represents — OraSure Technologies, Inc.
KRAUSE Jennifer — OraSure Technologies, Inc.
MILLER Tiffany — OraSure Technologies, Inc.
RADER Rebecca — OraSure Technologies, Inc.

Catalog of OraSure Technologies, Inc.

20 devices · 20 families

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OraQuick HIV Self-Test, CE, UK, 25 Count Kit1001-06001 version
OraQuick HIV Self-Test, Single Unit, CE, Spain/Portugal1001-0601U1 version
OraQuick HIV Self-Test, Single Unit, CE, UK1001-0600U1 version
OraQuick HIV Self-Test, Single Unit, CE, Germany1001-0602U1 version
OraQuick HIV Self-Test, CE, Germany, 25 Count Kit1001-06021 version
OraQuick HIV Self-Test, Single Unit, CE, France/Italy1001-0603U1 version
OraQuick HIV Self-Test, CE, Spain/Portugal, 25 Count Kit1001-06011 version
OraQuick HIV Self-Test, CE, France/Italy, 25 Count Kit1001-06031 version
OraQuick HIV Self-Test, Single Unit, CE, Bulgaria/Romania1001-0627U1 version
OraQuick HIV Self-Test, CE, Romania/Bulgaria, 25-Count Kit1001-06271 version
OraQuick HIV Self-Test, Single Unit, CE, Poland 1001-0628U1 version
OraQuick HIV Self-Test, CE, Poland, 25 Count Kit1001-06281 version
OraQuick HIV Self-Test, Single Unit, CE, Greece/Cyprus1001-0629U1 version
OraQuick HIV Self-Test, CE, Greece/Cyprus, 25 Count Kit1001-06291 version
OraQuick HIV Self-Test, Single Unit, CE, Slovakia/Czech1001-0630U1 version
OraQuick HIV Self-Test, CE, Slovakia/Czech, 25 Count Kit1001-06301 version
OraQuick HCV Rapid Antibody Test, 100 Count1001-02741 version
OraQuick HCV Rapid Antibody Test, 25 Count1001-02701 version
OraQuick HCV Rapid Antibody Test Kit Controls1001-02781 version
OraQuick HCV Rapid Antibody Test, Pouched Device3001-21411 version

Browse all 20 products