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Löwenstein Medical SE & Co. KG

Active in EUDAMED

Germanyfrom SRN EUDAMED SRN DE-MF-000006028

Devices
14
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

What Löwenstein Medical SE & Co. KG makes

Löwenstein Medical produces reusable and disposable neonatal lung test devices, including the LM Neonatal Testlung, as well as various sizes of bonnets for respiratory therapy applications. Their portfolio also includes single-use expiratory valve sets and specific ventilation accessories like the leon plus and LEONI 4 systems.

The company’s devices are classified under EU medical device regulations as Class I and Class IIb, with listings maintained in the EUDAMED database. Löwenstein Medical is headquartered in Germany.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

Newest first, rows 1-14 of 14

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  • leon plus Wand Ref 0200011

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • leon plus Ref 0200010

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Leoni 4 Ref 0730000

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Bonnets small Ref nj1515-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Bonnets xx small Ref nj1513-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Bonnets x small Ref nj1514-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • LM Neonatal Testlung, Reusable Ref 0217043v02bg

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Bonnets xx large Ref nj1519-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Bonnets x large Ref nj1518-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Single use expiratory valve set Ref 0217026v1bg

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Bonnets xxx large Ref nj1520-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Bonnets medium Ref nj1516-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • LM Neonatal Testlung, Disposable Ref 0217043v01bg

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Bonnets large Ref nj1517-10e

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-14 of 14

Company details

EUDAMED SRN
DE-MF-000006028
EU VAT number
DE270737704
EUDAMED status
Active
EUDAMED registered name
Löwenstein Medical SE & Co. KG
EUDAMED abbreviated name
LM
Registered address
80, Arzbacher Strasse, 56130, Bad Ems, Germany
Phone
+49 2603 96 00 0
PRRC contact
Christian Ochtendung(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 5 Sep 2028

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 1011391-1 Active

    Quality management system EU MDR

    Issued
    6 Sep 2023
    Expires
    5 Sep 2028

From the company website

Read 18 Oct 2026

Löwenstein Medical: Over 35 years of innovation in ventilation & respiratory therapy. From diagnosis to homecare, we improve quality of life. Learn more!

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Löwenstein Medical SE & Co. KG have in the registry?

The registry currently lists 14 devices for Löwenstein Medical SE & Co. KG. Devices recorded under merged duplicate company entries are counted once.

Which registries list Löwenstein Medical SE & Co. KG's devices?

Among its 14 most recently registered devices, Löwenstein Medical SE & Co. KG has devices listed in EUDAMED (14 devices).

What risk classes do Löwenstein Medical SE & Co. KG's devices fall under?

Among its 14 most recently registered devices, the classes recorded for Löwenstein Medical SE & Co. KG's devices are Class I and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Löwenstein Medical SE & Co. KG?

EUDAMED lists 1 certificate for Löwenstein Medical SE & Co. KG (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 6 Sep 2023.

What are the newest devices from Löwenstein Medical SE & Co. KG in the registry?

The most recently registered devices listed for Löwenstein Medical SE & Co. KG include leon plus Wand, leon plus, LEONI 4 and Bonnets small.

Generated automatically from registry data and not verified by a human reviewer.