Cytocell Limited
GB-MF-000016893 · United Kingdom · CAMBRIDGE
Cytocell Limited is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Authorised representative in the Union: Sysmex Europe SE.
Devices declared under this manufacturer
- ATM Deletion Probe
- BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe
- BCR/ABL (ABL1) Translocation, Dual Fusion Probe
- CBFB Breakapart Probe
- CKS1B/CDKN2C (P18) Amplification/Deletion Probe
- Del(20q) Deletion Probe
- Del(5q) Deletion Probe
- Del(7q) Deletion Probe
- FAST FISH Prenatal Enumeration Probe kit
- FAST PML/RARα (RARA) Translocation, Dual Fusion Probe
- IGH/MAF Plus v2 Translocation, Dual Fusion Probe
- P53 (TP53)/ATM Combination Deletion Probe
Showing 12 of 60 declared devices.
Catalogue references include CE-LPA 001-S, CE-LPF 001-S, CE-LPH 007-S, CE-LPH 011, CE-LPH 024-S, CE-LPH 038-S.
European nomenclature codes declared: W01060299, W0106010301,W0106010302,W0106010304,W0106010305, W01060208, W0106010301,W0106010304, W01030703, W01060211.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CYTOCELL LIMITED (GB) · FDA 9710378 |
| Devices in EUDAMED | 60 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 60 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CYTOCELL LIMITED |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 2018-11-15 |
Licence types: Device Family (5).
Licensed under: CYTOCELL AQUARIUS ANALYTE SPECIFIC REAGENT DEL, CYTOCELL AQUARIUS ASR TRANSLOCATION PROBES, CYTOCELL AQUARIUS ASR BREAKAPART PROBES, CYTOCELL AQUARIUS ASR AMPLIFICATION PROBES, CYTOCELL AQUARIUS ASR ENUMERATION PROBES.
North American profile: Both markets. Cytocell Limited is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IVDR 747622 | supplemented | 2028-03-08 |