HÄLSA Pharma GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000007407
- Devices
- 312
- Registrations
- EUDAMED
Catalogue
Zeezout Neusspray 3% NAS 20ml HPH Ref 321429
DulcoEase Hydrate Ref 795089
DulcoSoft Constipation Ref 777371
Lefax® intens Flüssigkapseln Ref 86987015
Rifluduo Ref 307573308
Rifluduo Ref 318571391
Reloxan Ref 305573391
Lefax® extra Flüssigkapseln Ref 86987023
Reloxan Ref 301573302
Reloxan Ref 301574308
Reloxan Ref 304573308
Phytosun Aroms Toux enfant seche e grasse Ref 9531890
Dr. Storz Aloe Vera 97, 5 % Gel Ref 4000062
Bronwel Kids+Family Ref 9532307
Sinulind® Abschwellendes Nasenspray Ref 9904340
Tussirex Ref 9532225
Bronwel Kids+Family Ref 9532309
Reloxan Ref 317571308
Medistus Antivirus Ref 42517781MD234CR
Dulcogas Ballonnements Ref MD317
Reloxan Ref 301574391
tetesept Meerwasser Nasenspülsalz Ref 200000678
Iovir Throat Spray Ref P360A09
Fructosin Ref 161904
DulcoSoft Ref 706152
Abtei Husten Saft mit Honig und Eibisch Ref 042517781MD323CR
Broncophen Kids Köhasiirup Ref 9532130
Bronchodual Infantil Ref 9531887
Eucerin Actinic Control MD SPF 100 Ref 83586-00000-03
Otowaxol Sine Ref 3002405
Refluthin Ref 1571373
Bronchodual Alivio Rapido Ref 9532125
Ozovit® MP Ref 0010902
tetesept Meerwasser Nasenspray Ref P27502
Reloxan Ref 304572373
tetesept Pflanzlicher Reizhusten Stiller Saft Ref 200002070
Rifluduo Ref 307572391
Mucosolvan Natural Dry Cough Ref 946170
Bisolduo Siirappi/ Bisolduo Sirap Ref 792583
Refluthin Ref 302572302
tetesept Meerwasser Nasenspülsalz Ref 200003232
Rifluduo Ref 318571302
Reloxan Ref 301573308
Rifluduo Ref 307573391
Reloxan Ref 304573302
Refluthin Ref 574391
Tussirex Ref 9532077
Rifluduo Ref 307574302
Refluthin Ref 302572373
Showing 151-200 of 312
Company details
- EUDAMED SRN
- DE-MF-000007407
- SRN (system / procedure pack)
- DE-PR-000043992
- EUDAMED status
- Active
- EUDAMED registered name
- HÄLSA Pharma GmbH
- Registered address
- 5, Maria-Goeppert-Str., 23562, Luebeck, Germany
- [email protected]
- PRRC contact
- Karin Klose
EUDAMED certificates
6 certificates5 valid, 1 expiredMDR 6next expiry 13 Jul 2027
Notified body 0482 6 certificates
- 13980GB450260910 Issued
Technical documentation EU MDR
- Issued
- 10 Sep 2026
- Expires
- 9 Sep 2031
- 3558GB448260917 Supplemented
Quality management system EU MDR
- Issued
- 17 Sep 2026
- Expires
- 28 Jul 2031
- Reason
- Change approved
- 20527GB450260324 Supplemented
Technical documentation EU MDR
- Issued
- 24 Mar 2026
- Expires
- 29 Sep 2030
- Reason
- Add device or group
- 20416GB450260423 Supplemented
Technical documentation EU MDR
- Issued
- 23 Apr 2026
- Expires
- 26 Feb 2029
- Reason
- Change approved
- 20218GB450220714 Issued
Technical documentation EU MDR
- Issued
- 14 Jul 2022
- Expires
- 13 Jul 2027
- 3558GB448260420 Expired
Quality management system EU MDR
- Issued
- 20 Apr 2026
- Expires
- 28 Jul 2026
- Reason
- Add device or group
What HÄLSA Pharma GmbH makes
HÄLSA Pharma GmbH manufactures reusable device sterilization and disinfection containers, as well as a range of oral and nasal pharmaceutical formulations, including lozenges, nasal sprays, syrups, and capsules. Notable products include Simeticone Vegicaps® for digestive relief, Espumisan GOLD for infant colic, and nasal hygiene solutions like Just Nasendusche. The portfolio also covers respiratory treatments such as Tussirex Junior and Stryphnasal® N Nasenstifte, as well as otic preparations like Otodolor® direkt. Additional offerings include MD Marshmallow A for throat soothing and Dr. Böhm® optico for eye care.
The company’s products are classified under EU medical device regulations, including Class I, Class IIa, Class IIb, and Class III devices. All relevant products are registered in the EU’s eudamed database. The manufacturer is based in Germany.