HÄLSA Pharma GmbH
DE-MF-000007407 · Germany · Luebeck
HÄLSA Pharma GmbH is registered in the European database on medical devices as a manufacturer, with 286 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 120 |
|---|---|
| Class I | 137 |
| Class IIb | 29 |
Most frequent device types declared: 0,9 %ige isotonische Natriumchloridlösung, Detall, Dr. Böhm optico®, Eucerin Actinic Control SPF 100, MD Marshmallow.
Among these devices, 15 are declared sterile.
Devices declared under this manufacturer
- 0,9 %ige isotonische Natriumchloridlösung
- Abtei Kinder Husten Saft
- Bronchostop Max8in1 Voor meerdere symptomen 20 hoestpastilles
- Detall
- Dr. Böhm optico®
- EspiForte
- Espumisan MAX
- Eucerin Actinic Control \nMD SPF 100
- Kochsalz 3% Inhalat Pädia
- Pump Dosing System 1ml
- Refluthin
- Reloxan
Showing 12 of 286 declared devices.
Catalogue references include 112, 301574308, 302573373, 306574308, 317571308, 572391.
European nomenclature codes declared: G0401, Q030199, V9099, R060203, U0803, A99.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 286 |
| 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 | 257 |
|---|---|
| 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. HÄLSA Pharma GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
3558GB448260709 | reissued | 2031-07-28 |
3558GB448260420 | supplemented | 2026-07-28 |
20527GB450260324 | supplemented | 2030-09-29 |
20416GB450260423 | supplemented | 2029-02-26 |
20218GB450220714 | issued | 2027-07-13 |