Flexicare Medical Limited
GB-MF-000034163 · United Kingdom · Mountain Ash
Flexicare Medical Limited is registered in the European database on medical devices as a manufacturer, with 2 533 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 506 |
|---|---|
| Class IIb | 27 |
Most frequent device types declared: Berman, Guedel.
Among these devices, 1 207 are declared sterile, 11 reusable, 415 active, 33 with a measuring function.
Authorised representative in the Union: Flexicare EU Ops Ltd.
Devices declared under this manufacturer
- DualGuard
- EZ-Flow
- FlexiCath
- Flexicare
- Magill Forceps
- NasoClear
- NasoSafe
- ProVu
- Provu Rigid Stylet
- Urimeter
- VentiSeal
- WyCath
Showing 12 of 2 533 declared devices.
Catalogue references include 032-10-044TU, 032-10-321, 033-10-042TU, 038-971-075, 038-975-090 MEDI, 040-02-0140.
European nomenclature codes declared: R9002, R01030201, Z12021003, R03010202, R03010201, R01030101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FLEXICARE MEDICAL LTD. (GB) · FDA 8021995 |
| Devices in EUDAMED | 2 533 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 2 533 |
|---|---|
| Found in the U.S. device database | 826 |
| Share | 32.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | FLEXICARE MEDICAL LTD. |
What it holds in Canada
| Licences on record | 56 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 56 |
| First licensed | 2011-12-14 |
Licence types: Device Family (30), Device Group Family (15), System (9), Single Device (2).
Licensed under: MAXINEB NEBULISERS, VENTICARE BREATHING SYSTEMS, OXYGEN AND AEROSOL MASKS, FLEXICARE BACTERIAL/VIRAL FILTERS, FLEXICARE GUEDEL AIRWAYS, VENTICAIRE OXYGEN & AEROSOL THERAPY PRODUCTS -.
North American profile: Both markets. Flexicare Medical Limited is registered in both the United States and Canada.