HÄLSA Pharma GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000007407
- Devices
- 312
- Registrations
- EUDAMED
Catalogue
Aspecton Hustenstiller Ref 702700
Aspecton Nasenspray Ref MD343
Simeticone Vegicaps® 250mg Ref V5408.O.K
Dr. Böhm® optico Ref Apom-MD354-00001
Pump Dosing System Ref 31087379
MD Marshmallow C/F Ref MD323
Kochsalz 3% Inhalat Pädia Ref MD360
Dr. Storz® Aloe Vera 97.5 % Gel Ref EST-MD318-00004
DulcoSoft Ref 795089
Detall Ref 100001
Gynaedron Ref FRT00202
DulcoSoft Ref many
Showing 301-312 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.