G. Heinemann Medizintechnik GmbH
DE-MF-000009705 · Germany · Kaltenkirchen
G. Heinemann Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 60 |
|---|
Among these devices, 21 are declared active, 8 with a measuring function.
Devices declared under this manufacturer
- Cannula irrigation system, 110 mm
- Combi 4000-M (a combination of tympanometry and rhinomanometry)
- ENG 4000 (Electronystagmograph)
- ENT treatment unit MODULA Paris
- Ear rinsing bowl
- Nebulizer for liquid complete with bottle
- Politzer olive L (MODUL A-M, Modula-L)
- Politzer olive M
- Secretion jar -
- Splash guard
- Tymp 4000 (Tympanometer)
- US 4000 (Ultrasound scanner)
Showing 12 of 60 declared devices.
Catalogue references include 0130-50030, 0130-50500 / 12-3104, 0140-21302, 0140-60101, 13-2100, 5140-21303.
European nomenclature codes declared: Q0399, Z12149099, Z12149005, Z12159010, Z11040199, Z12120124.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 60 |
| 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 | 60 |
|---|---|
| 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. G. Heinemann Medizintechnik GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1224GB448241107 | issued | 2028-03-31 |