DM Orthotics Ltd
GB-MF-000008260 · United Kingdom · Redruth
DM Orthotics Ltd is registered in the European database on medical devices as a manufacturer, with 150 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 150 |
|---|
Most frequent device types declared: DM 03, DM 05, DM 09, DM 17, DM 32.
Authorised representative in the Union: MedEnvoy Global BV.
Devices declared under this manufacturer
- Adult Vest size M
- Adult Vest size XS
- Child Leggings size 1
- Child Leggings size 2
- Child Shorts size 8
- Child Single Shoulder Left size 1
- Custom Advanced Suit
- Custom Vest with Sleeves
- Sensory Leggings Adult size XL
- Sensory Leggings Adult size XXL
- Sensory Leggings Child size 1
- Sensory Vest Adult size M
Showing 12 of 150 declared devices.
Catalogue references include DM 05, DM 09, SENLA5, SENLA6, SENLC1, SLC 2.
European nomenclature codes declared: Y061299, Y060621, Y060399, Y0699, Y060699, Y061215.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DM ORTHOTICS LTD (GB) · FDA 3009113808 |
| Devices in EUDAMED | 150 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 150 |
|---|---|
| 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: United States only. DM Orthotics Ltd is registered in the United States but was not found in the Canadian register.