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Zakłady Farmaceutyczne Polpharma SA

Active in EUDAMED

Polandfrom SRN EUDAMED SRN PL-MF-000010601

Devices
15
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 Zakłady Farmaceutyczne Polpharma SA makes

Zakłady Farmaceutyczne Polpharma SA manufactures topical pharmaceutical gels, including Xylogel hydro, a gel formulation for local analgesic and anti-inflammatory use, and LACRIMAL, a product designed for ocular surface protection and lubrication. These products are intended for direct application to skin or ocular tissues, addressing pain relief and eye care needs.

The company’s portfolio includes devices classified under Class I and Class IIb, with products registered in the EU’s eudamed database. The manufacturer operates from Poland, adhering to regulatory requirements for medical devices within the European Union.

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

Catalogue15

Newest first, rows 1-15 of 15

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  • Simetigast Forte Baby Ref WBOB-0205-800

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Polpharma 0, 9% NaCl

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Simetigast Forte Ref WTIG-0328-800

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Pyralgina Termo Hot Ref PRLG-2200-000

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Polpharma 0, 9% NaCl Ref NTCH-4600-000

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Simetigast Forte Ref WTIG-0200-000

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Simetigast Forte Ref WTIG-0100-000

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Bobotic Forte Ref WBOB-0200-000

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Simetigast Forte Ref WTIG-0500-000

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Pyralgina Termo Hot Ref PRLG-1905-800

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Pyralgina Termo Hot Ref PRLG-2700-000

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Polpharma 0, 9% NaCl

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Simetigast Forte Ref WTIG-0128-800

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Xylogel hydro Ref ALFR-0400-000

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Lacrimal Ref LTDR-0500-000

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

Rows 1-15 of 15

Company details

EUDAMED SRN
PL-MF-000010601
EU VAT number
592-02-02-822
EUDAMED status
Active
EUDAMED registered name
Zakłady Farmaceutyczne Polpharma SA
Registered address
19, Pelplińska, 83-200, Starogard Gdański, Poland
Phone
+48783838970
PRRC contact
Magdalena Lewandowska(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 17 Jul 2029

EUDAMED certificates (1)

TUV Rheinland Italia SRL 1936 1 certificate

  • ITH 1503348 1 Active Amended

    Quality management system EU MDR

    Issued
    14 Jul 2025
    Expires
    17 Jul 2029
    Reason
    Other

Frequently asked questions

How many devices does Zakłady Farmaceutyczne Polpharma SA have in the registry?

The registry currently lists 15 devices for Zakłady Farmaceutyczne Polpharma SA. Devices recorded under merged duplicate company entries are counted once.

Which registries list Zakłady Farmaceutyczne Polpharma SA's devices?

Among its 15 most recently registered devices, Zakłady Farmaceutyczne Polpharma SA has devices listed in EUDAMED (15 devices).

What risk classes do Zakłady Farmaceutyczne Polpharma SA's devices fall under?

Among its 15 most recently registered devices, the classes recorded for Zakłady Farmaceutyczne Polpharma SA's devices are Class I, Class IIa, Class IIb and Class III. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Zakłady Farmaceutyczne Polpharma SA?

EUDAMED lists 1 certificate for Zakłady Farmaceutyczne Polpharma SA (quality management system) under MDR. The most recent was issued on 14 Jul 2025.

What are the newest devices from Zakłady Farmaceutyczne Polpharma SA in the registry?

The most recently registered devices listed for Zakłady Farmaceutyczne Polpharma SA include Simetigast Forte Baby, Polpharma 0,9% NaCl, Simetigast Forte and Pyralgina Termo Hot.

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