Opitek International
DK-MF-000001594 · Denmark · Vedbæk
Opitek International is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 24 |
|---|
Devices declared under this manufacturer
- Back Support, Cushion Holder. For Hip Fix xx15 models
- Front Lower Support, Cushion Holder. For Hip Fix xx15 models
- Front Upper Support, Cushion Holder. For Hip Fix xx15 models
- Hip Fix 1915, Upgrade System. For single use pads, 2015-50-1
- Hip Fix 2000, Complete lateral positioning system w/fixed pads
- Hip Fix 2015, Bariatric, Complete System. For single use pads, 2015-50
- Hip Fix 2015, Complete System. For single use pads, 2015-50-1
- Hip Fix 2015, Upgrade System. For single use pads, 2015-50-1
- Lift string, velcro, single use
- PediStirrup. Pediatric Leg Support, complete system
- Support Cushion, large, for Hip Fix. Incl. 2 mounting screws
- Support Cushion, small, for Hip Fix. Incl. 2 mounting screws
Showing 12 of 24 declared devices.
Catalogue references include 0871900001-T, 2000-01, 2000-02, 2015-10, 2015-100, 2015-200.
European nomenclature codes declared: Z12011299, Z12011285, Y180939, V0805030102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| 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. Opitek International was not found in either the U.S. or the Canadian register.