Manufacturer's By Device Histology/cytology/microbiology image-analysis interpretive software IVD-Histology/cytology/microbiology image-analysis interpretive software IVD

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
3DHISTECH KftH-1141

Öv utca. 3.
Budapest Öv utca. 3.

Hungary
Sysmex UK LtdSysmex House Garamonde Drive
Wymbush
Milton Keynes
Buckinghamshire MK8 8DF

England United Kingdom
11/08/202119925
BD Kiestra B.V.Marconilaan 6

Drachten
JC 9207

Netherlands
Becton Dickinson U.K. Limited1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom
12/20/202120673
Indica Labs8700B Education Place Northwest

Albuquerque
87114

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
01/17/202221293
INFINITT Healthcare Co. Ltd.12F Daerung Post Tower 3 27 Digital-ro 34-gil Guro-gu

Seoul
08378

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
03/22/202223405
Invenio Imaging Inc.2310 Walsh Avenue

Santa Clara
95051

United States
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
06/15/202224904
Oxford Cancer BiomarkersMagdalen Centre 1 Robert Robinson Avenue

Oxford
Oxfordshire OX4 4GA

United Kingdom





10/13/20166713
Paige.AI Inc.11 Times Square 37th Floor

New York
New York 10036

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
01/23/202222260
Panakeia Technologies LimitedSalisbury House Station Road

Cambridge
CB1 2LA

England United Kingdom





07/20/202116233
Ventana Medical Systems Inc.1910 E Innovation Park Drive

Tucson
AZ 85755

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
03/26/202112951
Visiopharm A/SAgern Allé 24

Hørsholm
2970

Denmark
Visiopharm UK LimitedCentrum House 36 Station Road

Egham
Surrey TW20 9LF

England United Kingdom
01/13/202221304