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ibesan MAX

by Natur Produkt Zdrovit Sp. z o.o. 5 variants

Ref 010-IBMAXZModel Zawiesina w saszetkach do stosowania wspomagająco w jelicie drażliwym. Suspension in sachets intended for use as supportive treatment in patients with irritable bowel syndrome.

Active European Union

CE MDR

Valid until

12 Feb 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier TUV NORD Polska Sp. z o.o

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTNP/MDR/0048/5905/2026 Date13 Oct 2026IssuedStatusActive expires 12 Feb 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • TNP/MDR/0048/5905/2026 Active Supplemented

    Quality management system EU MDR

    Certifier
    TUV NORD Polska Sp. z o.o 2274
    Issued
    13 Oct 2026
    Expires
    12 Feb 2029
    Reason
    Add device or group
  • TNP/MDR/0048/5905/2026 Active Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    TUV NORD Polska Sp. z o.o 2274
    Issued
    13 Feb 2026
    Expires
    12 Feb 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
ibesan MAX
ibesan S.O.S.
Model / Reference
Zawiesina w saszetkach do stosowania wspomagająco w jelicie drażliwym. Suspension in sachets intended for use as supportive treatment in patients with irritable bowel syndrome., 010-IBMAXZ
Primary DI / UDI-DI
05906204023935, 05906670944789, 05906204024857
Basic UDI-DI
5904730876MD_NPZ_0217W
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class IIb
EU market of registration
Poland
Lithuania

Manufacturer details

EUDAMED SRN
PL-MF-000010540

Other devices from Natur Produkt Zdrovit Sp. z o.o.

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    Class IIb

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See all devices from Natur Produkt Zdrovit Sp. z o.o. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No