Chalice Medical Ltd
GB-MF-000010617 · United Kingdom · Worksop
Chalice Medical Ltd is registered in the European database on medical devices as a manufacturer, with 126 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 125 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: Ancillary Components, Bypass Coated Tubing Pack, Bypass Tubing Pack including Haemoconcentrator, ECMO Coated Tubing Pack inc Oxygenator, ECMO Tubing Pack including Oxygenator.
Among these devices, 113 are declared sterile, 1 active.
Authorised representative in the Union: MedEnvoy Global BV.
Devices declared under this manufacturer
- 3/8 x 3/8 Tubing Pack
- Adult ECLS/ECMO Tubing Pack - Coated
- Aspiradores CEC Tubing Pack
- Coated Lineas CEC Tubing Pack
- ECMO Tubing Pack with Adult Midi Paragon PMP Oxygenator
- ECMO Tubing Pack with Infant Paragon PMP Oxygenator
- Haemo Tubing Set
- Haemofilter Tubing Pack
- High Flow Pigtail
- Holder for Integrated Paragon Oxygenator
- Loop 5 Tubing Pack
- Neonatal Bridge Tubing Pack
Showing 12 of 126 declared devices.
Catalogue references include CM5731, CME54004, CME72004, CME90003, CME90006, CME90034.
European nomenclature codes declared: C03010301, C03010102, F0301, V80, V9099, A0699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Chalice Medical Ltd (GB) · FDA 3013267343 |
| Devices in EUDAMED | 126 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 126 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CHALICE MEDICAL LIMITED |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| Class 3 devices | 1 |
| Class 4 devices | 1 |
| First licensed | 2010-12-13 |
Licence types: Device Family (3), Device Group Family (1), Single Device (1).
Licensed under: TUBING PACKS, PARAGON OXYGENATOR, PARATHERM, PRE-CONNECTED HAEMOCONCENTRATOR SET (TUBING PA, PARATHERM ACCESSORY - WATER LINES WITH HANSEN .
North American profile: Both markets. Chalice Medical Ltd is registered in both the United States and Canada.