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Flen Health Pharma

Active in EUDAMED

Belgiumfrom SRN EUDAMED SRN BE-MF-000000258

Devices
21
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices
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  • Flaminal Hydro Ref 1010-C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1017-N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1034-DCN

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1016-TR

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1015-TR

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1034-D

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1012-U

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1015-E

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1017-D

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1015-I

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1015-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1017-C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1033-DCN

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1017-I

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1033-D

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1016-I

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1016-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1015-C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1017-TR

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Flaminal Forte Ref 1016-C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Extracalm Ref 1014-B

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

Rows 1-21 of 21

Company details

EUDAMED SRN
BE-MF-000000258
EU VAT number
BE 0473.295.959
EUDAMED status
Active
EUDAMED registered name
Flen Health Pharma
EUDAMED abbreviated name
Flen Health
Registered address
87, Blauwesteenstraat, 2550, Kontich, Belgium
Phone
+32 3 825 70 63
PRRC contact
Egon Kunnen(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 1 Nov 2027

EUDAMED certificates (2)

DEKRA Certification B.V. 0344 2 certificates

  • 2253359CE01 Active Amended

    Quality management system EU MDR

    Issued
    8 Dec 2025
    Expires
    1 Nov 2027
    Reason
    Mnf ar change
  • 2253359CE03 Active

    Quality management system EU MDR

    Issued
    3 Jun 2026
    Expires
    1 Nov 2027

From the company website

Read 18 Oct 2026

Flen Health is a medical device company providing innovative wound and skin healing solutions for healthcare professionals and patients worldwide.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Flen Health Pharma have in the registry?

The registry currently lists 21 devices for Flen Health Pharma. Devices recorded under merged duplicate company entries are counted once.

Which registries list Flen Health Pharma's devices?

Among its 21 most recently registered devices, Flen Health Pharma has devices listed in EUDAMED (21 devices).

What risk classes do Flen Health Pharma's devices fall under?

Among its 21 most recently registered devices, the classes recorded for Flen Health Pharma's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Flen Health Pharma?

EUDAMED lists 2 certificates for Flen Health Pharma (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-06-03.

What are the newest devices from Flen Health Pharma in the registry?

The most recently registered devices listed for Flen Health Pharma include Flaminal Hydro, Flaminal Forte and Extracalm.

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