RefLab Aps
DK-MF-000021844 · Denmark · Hvidovre
RefLab Aps is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 501, ver 3.0-0612.
Devices declared under this manufacturer
- OPA Disc 25 mg, 20 pcs
- OPA Disc 5 mg, 10 pcs
- Pipes buffer 1 L
- Pipes buffer 100 mL
- Pipes buffer 900 mL
- Preparation Vial (IL-3)
- Release 13AUG2012
- Release 23SEP2013
- Stop reagent (HClO4) 1 L
- Stop reagent (HClO4), 100 mL
- Stripping buffer, 100 mL
- Wash buffer 200 mL
Showing 12 of 31 declared devices.
Catalogue references include RLA706.1000, RLA708, RLR006, RLR007S.50, RLR007W.200, RLR011.
European nomenclature codes declared: W0201020285, W0201020282, W0201020280, W0102152299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 31 |
| 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 | 31 |
|---|---|
| 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. RefLab Aps was not found in either the U.S. or the Canadian register.