HomeUnited Kingdom of Great Britain and Northern IrelandCYTOCELL LIMITED

CYTOCELL LIMITED

United Kingdom of Great Britain and Northern Ireland · Cambridge
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
6 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IVD Class 1 1IVD Class 3 3
HKHong KongMDACS
4valid listings
IVD C 4
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States4 registration records, 2 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: CYTOCELL LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Cambridge

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Company number
04231155
Registration status
Active
Legal form
Private Limited Company
Incorporated
2001-06-08
Principal activity
86900 - Other human health activities
Registered address
OXFORD GENE TECHNOLOGY 418 CAMBRIDGE SCIENCE PARK, CAMBRIDGE, CB4 0PZ

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12018 · DEN170070
12025 · DEN240067

FDA listed device types

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies 1Revumenib Eligibility Detection System 1General Purpose Reagent 1Reagents, Specific, Analyte 1

Registration details (sample)

MarketIdentifierNameClass / date
USDEN240067KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)2025-09-19
USDEN170070MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit2018-12-21
CA102210CYTOCELL AQUARIUS ASR PAINTING PROBESClass II

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