Kobayashi Healthcare Europe Limited
GB-MF-000012185 · United Kingdom · LONDON
Kobayashi Healthcare Europe Limited is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: Boots Back Pain Direct 4P, Cura-Heat Acute Back Pain Max Size Indirect 2P, Cura-Heat Arthritis/Knee Pain 4P&1Wrap, Cura-Heat Arthritis/Knee Pain Refill 6P, Cura-Heat Back and Shoulder Indirect 3P.
Authorised representative in the Union: Medical Device Management Ltd.
Devices declared under this manufacturer
- Boots Back Pain Direct 4P
- Cura-Heat Acute Back Pain Max Size Direct 2P
- Cura-Heat Acute Back Pain Max Size Indirect 2P
- Cura-Heat Arthritis/Knee Pain 4P&1Wrap
- Cura-Heat Arthritis/Knee Pain Refill 6P
- Cura-Heat Back and Shoulder Indirect 3P
- Cura-Heat Back and Shoulder Pain Direct 7P
- Cura-Heat Back and Shoulder Pain Indirect 1P
- Cura-Heat Back and Shoulder Pain Indirect 3+1P
- Cura-Heat Neck and Shoulder Pain Indirect 2P
- Cura-Heat Period Pain 3P
- Cura-Heat Wide Cover Direct 2P
Showing 12 of 17 declared devices.
Catalogue references include Boots Back Pain Direct 4P, Cura-Heat Acute Back Pain Max Size Indirect 2P, Cura-Heat Arthritis/Knee Pain 4P&1Wrap, Cura-Heat Arthritis/Knee Pain Refill 6P, Cura-Heat Back and Shoulder Indirect 3P, Cura-Heat Back and Shoulder Pain Indirect 1P.
European nomenclature codes declared: Z12069099, V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 17 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Kobayashi Healthcare Europe Limited was not found in either the U.S. or the Canadian register.