Penlon Limited
GB-MF-000025115 · United Kingdom · Abingdon
Penlon Limited is registered in the European database on medical devices as a manufacturer, with 123 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 106 |
|---|---|
| Class IIb | 17 |
Most frequent device types declared: AV-S, Sigma Delta, Sigma Delta MRI.
Among these devices, 52 are declared active.
Authorised representative in the Union: Obelis s.a..
Devices declared under this manufacturer
- Crystal Metal Miller / Disposable Laryngoscope Blade Size 4, Box of 20
- Diamond Fibrelight Macintosh / Laryngoscope Blade Size 00
- Diamond Fibrelight Macintosh / Laryngoscope Blade Size 1
- Diamond Fibrelight Macintosh / Laryngoscope Blade Size 3
- Diamond Fibrelight Macintosh / Laryngoscope Blade Size 5
- Diamond Fibrelight Miller / Laryngoscope Blade Size 2
- Diamond S / Video Laryngoscope
- Green System MRI Macintosh / Laryngoscope Blade Size 1
- Green System MRI Miller / Laryngoscope Blade Size 1
- Prima 320 Advance Anaesthetic Machine
- Prima 450 Anaesthetic Machine
- SC760 Low Suction Controller / Low, Remote with 44 mm rail clamp
Showing 12 of 123 declared devices.
Catalogue references include 310106, 410502S-M, 5010014, 5011302A, 50528, 50530.
European nomenclature codes declared: Z12021003, A0601010299, R9002, Z120309, Z1203010101, Z1203010180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PENLON LTD. (GB) · FDA 9610531 |
| Devices in EUDAMED | 123 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 123 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 11.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PENLON LIMITED |
North American profile: Both markets. Penlon Limited is registered in both the United States and Canada.