Kenex (Electro-Medical) Limited
GB-MF-000009022 · United Kingdom · Harlow, Essex
Kenex (Electro-Medical) Limited is registered in the European database on medical devices as a manufacturer, with 331 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 331 |
|---|
Most frequent device types declared: 1701/02 8x24cm.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- 1305-Mobile DR detector and cassette holder
- 300/LP110/005-3 Life Pulse 10 ECG Monitor suspension
- 311/DS/3.21 DS-020 high fold-down top & 43cm high curtain
- 312/DS/3.108 27x24cm High Lift Off Top
- 312/DS/3.42 51cm Wide Lift Off Top Shield
- 312/E Table mounted shields
- 313 Table mounted shields head end
- 333 Monitor Suspension Systems
- 333/LP110/1857/P/80 ECG 10 & Monitor System With Ceiling Plate (80cm)
- 350-Eyes and thyroid radiation shield
- 351-Upperbody radiation shield
- 354/P76/LED130F-0031 76x61cm shield & arm,column,LED130FLamp&AluTrack
Showing 12 of 331 declared devices.
Catalogue references include 311/DS/3.21, 312/E-012, 312/E-016/8, 313/A2-001, 333/1/510/0031, 350/34-001.
European nomenclature codes declared: Z11030503, T0399, Z12010701, Z12011299, T030499, V9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | KENEX (ELECTRO-MEDICAL) LTD. (GB) · FDA 9710585 |
| Devices in EUDAMED | 331 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 331 |
|---|---|
| Found in the U.S. device database | 281 |
| Share | 84.9 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Kenex (Electro-Medical) Limited is registered in the United States but was not found in the Canadian register.