ARCHImedline GmbH
AT-MF-000037501 · Austria · Vienna
ARCHImedline GmbH is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- Calibrator 7 for PEth from whole blood
- Column guard 001
- Control IV for PEth from whole blood
- Control set – Level I – III for PEth from whole blood
- HPLC Column 001
- HPLC column 2 for PEth from whole blood
- HPLC column for PEth from whole blood
- Mobile Phase 001
- Mobile Phase 002
- Mobile Phase for PEth from whole blood
- Optimization mix for PEth from whole blood
- PEth from whole blood
Showing 12 of 23 declared devices.
Catalogue references include A290-011, A290-012, A371-001, A371-010, A371-080, M001-02.
European nomenclature codes declared: W01019099, W0101050301, W02069080, W0101050399, W0101050199, W01010499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 23 |
| Country of registration | Austria |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 23 |
|---|---|
| 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. ARCHImedline GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IQMS/00010/0v002 | supplemented | 2031-07-08 |