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Rolf Kullgren AB

Active in EUDAMED

Swedenfrom SRN EUDAMED SRN SE-MF-000021108

Devices
41
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Rolf Kullgren AB makes

Rolf Kullgren AB manufactures Lactal Balans, a diagnostic device for assessing lactose intolerance by detecting hydrogen in breath samples, and Lactal Vaginal Gel, a topical gel designed for vaginal pH balancing and microbial support. These products are intended for clinical or at-home use to aid in digestive or vaginal health assessments.

The company’s portfolio is classified under EU Medical Device Regulation (MDR) as Class IIa devices, reflecting moderate risk levels. Both products are registered in the EU’s eudamed database, ensuring compliance with European Union medical device regulations. The manufacturer is based in Sweden.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue41

Newest first, rows 1-41 of 41

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  • Saugella Ref 30082

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 40016

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 30007

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • LactalBalance Ref 40002

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Intimo Help Ref 30076

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • LactalBalans Ref 40001

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lactobor Ref 40126

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Saugella poligyn 50+ Hydratation Intense Ref 30090

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Gynolind Ref 40020

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • GineCanesbalance Ref 30077

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Balance Activ Ref 28060416

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lactal Balance Ref 753479

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • HydralinBalance Ref 30004

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesten GYNO Balance Ref 40008

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 30062

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Balance Activ Ref 40019

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Saugella poligyn 50+ Gel Idratante Intenso Ref 30089

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 40007

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 30006

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 30058

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesten GYNO Balance Ref 30009

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lactofeel Ref 40139

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 30050

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • HydralinBalance Ref 30084

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Gynolind Balance Activ Ref 30069

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Sagella Ref 30085

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lactal Balans Ref 320865

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lactal Balans Ref 200895

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Canesbalance Ref 40012

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Balance Activ BV Treatment Gel Ref 507126

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Intimohelp Ref 30078

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Gyno-Canesbalance Ref 30005

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Saugella Ref 30083

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Saugella Ref 30087

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • GineCanesbalance Ref 30002

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Sagella poligyn 50+ Intensive Feuchtigkeit vaginal gel Ref 30088

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Sagella Ref 30081

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Intimohelp Ref 30075

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Saugella Ref 30086

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lactal Balans Ref 31-6TF

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lactal Vaginal Gel Ref 31-6TF0001

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

Rows 1-41 of 41

Company details

EUDAMED SRN
SE-MF-000021108
EU VAT number
556062-1491
EUDAMED status
Active
EUDAMED registered name
Rolf Kullgren AB
Registered address
4, Ågatan, 64622, Gnesta, Sweden
Phone
+46 158 130 30
PRRC contact
Sasika de Mel(public in EUDAMED)

Frequently asked questions

How many devices does Rolf Kullgren AB have in the registry?

The registry currently lists 41 devices for Rolf Kullgren AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list Rolf Kullgren AB's devices?

Among its 41 most recently registered devices, Rolf Kullgren AB has devices listed in EUDAMED (41 devices).

What risk classes do Rolf Kullgren AB's devices fall under?

Among its 41 most recently registered devices, the classes recorded for Rolf Kullgren AB's devices are Class IIa. Each device page shows its own class and authorisation.

What are the newest devices from Rolf Kullgren AB in the registry?

The most recently registered devices listed for Rolf Kullgren AB include SAUGELLA, Canesbalance, LactalBalance and Intimo Help.

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