Owen Mumford Ltd
GB-MF-000021000 · United Kingdom · Chipping Norton
Owen Mumford Ltd is registered in the European database on medical devices as a manufacturer, with 82 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 82 |
|---|
Most frequent device types declared: 12mm x 29G, AL-0710-00-00*, Empelvic male, LA-0404*, NU-0401-01-01*.
Among these devices, 46 are declared sterile, 9 active, 5 with a measuring function.
Authorised representative in the Union: Owen Mumford GmbH.
Devices declared under this manufacturer
- Amielle Comfort
- Autolet Plus
- CSYNC Autoinjector
- FreeStyle Lancing Device II
- Neurotips
- Ovaleap Pen
- Unistik 3 Comfort (28G 1.8mm)
- Unistik 3 Neo & Lab (18G 1.8mm)
- Unistik TinyTouch Preemie
- Unistik Touch Opaque (28G 1.8mm)
- Unistik Touch Opaque (30G 1.5mm)
- Unistik Touch Translucent (23G 2.0mm)
Showing 12 of 82 declared devices.
Catalogue references include 000287, 000361, 000363, 000408, 000711, AT2004BA000.
European nomenclature codes declared: V010401, L0509020101, A018006, N010199, Z12169004, U070399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Owen Mumford Limited (GB) · FDA 3003348846 |
| Devices in EUDAMED | 82 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 82 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 1.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OWEN MUMFORD LTD. |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 1999-07-20 |
Licence types: Device Family (5), Device Group (1), System (1).
Licensed under: AUTOPEN, AUTOLET, UNISTIK, UNILET LANCET, UNIFINE PENTIPS, AMIELLE.
North American profile: Both markets. Owen Mumford Ltd is registered in both the United States and Canada.