Heyer Medical AG
DE-MF-000014330 · Germany · Schwerin
Heyer Medical AG is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 15 |
|---|---|
| Class IIb | 6 |
Most frequent device types declared: Grundgerät, Grundgerät Antriebsgas O2, Grundgerät Englisch, Grundgerät Italienisch, Grundgerät mit Oxygen cylinder set Englisch.
Among these devices, 21 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- Hyrespira 5-in-1 Rapid Test
- LUVAR A
- LUVAR II
- LUVAR STA
- Mesh Nebulizer
- PORT+
- Pasithec
- Pasithec II
Showing 12 of 25 declared devices.
Catalogue references include 112000, 121100, 122005, 122006, 140005, 140006.
European nomenclature codes declared: Z12030102, W0105099099, Z12030104, Z1203010101, R060101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 25 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 25 |
|---|---|
| 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. Heyer Medical AG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 108227 0002 | issued | 2028-03-01 |
EU-TDA-FI-92091-800168-2026 | issued | 2031-07-14 |
EU-QMS-FI-88700-800168-2026 | issued | 2031-07-14 |