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HÄLSA Pharma GmbH

Active in EUDAMED

Germanyfrom SRN EUDAMED SRN DE-MF-000007407

Devices
312
Registrations
EUDAMED

Catalogue312

Newest first, page 4 of 7

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
PRRC contact
Karin Klose(public in EUDAMED)

EUDAMED certificates6

6 certificates5 valid, 1 expiredMDR 6next expiry 13 Jul 2027

EUDAMED certificates (6)

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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.