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 I | 137 |
|---|---|
| Class IIa | 120 |
| Class IIb | 29 |
Most frequent device types declared: Refluthin, MD Marshmallow, Eucerin Actinic Control SPF 100, Simeticone Capsules, MAR® Nasal Spray PLUS Care 20ml.
Among these devices, 15 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 286 |
| Country of registration | Germany |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
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 |