HÄLSA Pharma GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000007407
- Devices
- 312
- Registrations
- EUDAMED
At a glance
EU certificates
5 of 6 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 6 certificates
Catalogue
Mar® plus 3% Nosní sprej Ref MD312
weiche Nasensalbe nach Dr. Bader Ref 900735
Refluthin Ref 573373
Abtei Kinder Husten Saft Ref 9532059
Reloxan Ref 308572391
Reloxan Ref 320571302
Eucerin Actinic Control MD SPF 100 Ref 83586-00010-03
Glandomed® Medizinische Mundspüllösung Ref MD309
QUIXX protect Ref 9435
Refluthin Ref 1571391
Rifluduo Ref 307574373
Eucerin Actinic Control MD SPF 100 Ref 83586-06410-03
Reloxan Ref 305574308
Bronchostop Direct Adult Ref 9531888
Rifluduo Ref 319571302
Rifluduo Ref 307573373
Refluthin Ref 314571391
Sicca-Gynaedron Ref FRT00202
Rifluduo Ref 306573302
Refluthin Ref 574373
Broncho Quick Relief Ref 9532121
Medistus Antivirus Lonzenges Ref 42517781MD234CR
Rifluduo Ref 307572302
Reloxan Ref 301573391
Lefax® intens Flüssigkapseln Ref 86987007
Refluthin Ref 314571302
Refluthin Ref 572373
Lefax® extra Flüssigkapseln Ref 86987031
Rifluduo Ref 307573302
Reloxan Ref 301572391
Reloxan Ref 308573373
Reloxan Ref 317571373
EspiForte-Muster Ref CATA-MD301-00000
tetesept Hals & Rachen Akut Spray Ref 200002203
Reloxan Ref 308572373
Refluthin Ref 302573373
Vagiflor Ref 30010413
Reloxan Ref 301574302
tetesept Reizhusten & Hals Lutschtabletten (Discount) Ref 200001957
Eucerin Actinic Control MD SPF 100 Ref 83586-06400-03
Refluthin Ref 572302
tetesept Sodbrennen Akut Ref 11652
Reloxan Ref 304572308
Bepanthen Baby Ref MD345
Reloxan Ref 305574391
PHYTOXIL toux sèche Ref 792633
Kochsalz 0.9% Inhalat N Pädia® 2.5 ml Ref 3002204
Rifluduo Ref 306572308
Rifluduo Ref 306574302
Showing 1-50 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.
Frequently asked questions
How many devices does HÄLSA Pharma GmbH have in the registry?
The registry currently lists 312 devices for HÄLSA Pharma GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list HÄLSA Pharma GmbH's devices?
Among its 50 most recently registered devices, HÄLSA Pharma GmbH has devices listed in EUDAMED (50 devices).
What risk classes do HÄLSA Pharma GmbH's devices fall under?
Among its 50 most recently registered devices, the classes recorded for HÄLSA Pharma GmbH's devices are Class IIa, Class IIb and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for HÄLSA Pharma GmbH?
EUDAMED lists 6 certificates for HÄLSA Pharma GmbH (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2026-09-17.
What are the newest devices from HÄLSA Pharma GmbH in the registry?
The most recently registered devices listed for HÄLSA Pharma GmbH include Mar® plus 3% Nosní sprej, weiche Nasensalbe nach Dr. Bader, Refluthin and Abtei Kinder Husten Saft.