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Enterosgel®

by Bioline Products s.r.o. Czech Republic EUDAMED

EMDN G0401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08594161370116 Basic UDI-DIDate13 Mar 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Enterosgel
Primary DI / UDI-DI
08594161370116, 08594161371021, 08594161370949, 08594161370468, 08594161371472, 08594161371960, 08594161370451, 08594161371274, 08594161371847, 08594161371069, 08594161371939, 08594161371922, 08594161371007, 08594161370215, 08594161371854, 08594161370222, 08594161371700, 08594161370604, 08594161371946, 08594161370727, 08594161370208, 08594161370277, 08594161370956, 08594161371250, 08594161371878, 08594161371977, 08594161370109, 08594161371694, 08594161370130, 08594161371717, 08594161371298, 08594161370239, 08594161370628
Basic UDI-DI
B-08594161370116, B-08594161371021, B-08594161370949, B-08594161370468, B-08594161371472, B-08594161371960, B-08594161370451, B-08594161371274, B-08594161371847, B-08594161371069, B-08594161371939, B-08594161371922, B-08594161371007, B-08594161370215, B-08594161371854, B-08594161370222, B-08594161371700, B-08594161370604, B-08594161371946, B-08594161370727, B-08594161370208, B-08594161370277, B-08594161370956, B-08594161371250, B-08594161371878, B-08594161371977, B-08594161370109, B-08594161371694, B-08594161370130, B-08594161371717, B-08594161371298, B-08594161370239, B-08594161370628
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class IIa
Market of Registration
Latvia
Cyprus
Italy
Slovenia
Romania
Netherlands
Poland
Slovakia
Croatia
Czechia
Germany
Bulgaria
Estonia

Manufacturer details

EUDAMED SRN
CZ-MF-000034917

Other devices from Bioline Products s.r.o.

See all devices from Bioline Products s.r.o. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (33)

  • EUDAMED c4971fd0-854e-49ec-889f-c8d921d8526f 61 fields · synced 24 Oct 2026
  • EUDAMED 08594161371021|B-08594161371021 61 fields · synced 16 May 2026
  • EUDAMED 08594161370949|B-08594161370949 61 fields · synced 16 May 2026
  • EUDAMED 08594161370468|B-08594161370468 61 fields · synced 16 May 2026
  • EUDAMED 08594161371472|B-08594161371472 61 fields · synced 16 May 2026
  • EUDAMED 08594161371960|B-08594161371960 61 fields · synced 16 May 2026
  • EUDAMED 08594161370451|B-08594161370451 61 fields · synced 17 May 2026
  • EUDAMED 08594161371274|B-08594161371274 61 fields · synced 17 May 2026
  • EUDAMED 08594161371847|B-08594161371847 61 fields · synced 17 May 2026
  • EUDAMED 08594161371069|B-08594161371069 61 fields · synced 17 May 2026
  • EUDAMED 08594161371939|B-08594161371939 61 fields · synced 17 May 2026
  • EUDAMED 08594161371922|B-08594161371922 61 fields · synced 17 May 2026
  • EUDAMED 08594161371007|B-08594161371007 61 fields · synced 17 May 2026
  • EUDAMED 08594161370215|B-08594161370215 61 fields · synced 17 May 2026
  • EUDAMED 08594161371854|B-08594161371854 61 fields · synced 18 May 2026
  • EUDAMED 08594161370222|B-08594161370222 61 fields · synced 18 May 2026
  • EUDAMED 08594161371700|B-08594161371700 61 fields · synced 18 May 2026
  • EUDAMED 08594161370604|B-08594161370604 61 fields · synced 18 May 2026
  • EUDAMED 08594161371946|B-08594161371946 61 fields · synced 18 May 2026
  • EUDAMED 08594161370727|B-08594161370727 61 fields · synced 18 May 2026
  • EUDAMED 08594161370208|B-08594161370208 61 fields · synced 18 May 2026
  • EUDAMED 08594161370277|B-08594161370277 61 fields · synced 18 May 2026
  • EUDAMED 08594161370956|B-08594161370956 61 fields · synced 18 May 2026
  • EUDAMED 08594161371250|B-08594161371250 61 fields · synced 18 May 2026
  • EUDAMED 08594161371878|B-08594161371878 61 fields · synced 18 May 2026
  • EUDAMED 08594161371977|B-08594161371977 61 fields · synced 18 May 2026
  • EUDAMED 08594161370109|B-08594161370109 61 fields · synced 18 May 2026
  • EUDAMED 08594161371694|B-08594161371694 61 fields · synced 18 May 2026
  • EUDAMED 08594161370130|B-08594161370130 61 fields · synced 18 May 2026
  • EUDAMED 08594161371717|B-08594161371717 61 fields · synced 18 May 2026
  • EUDAMED 08594161371298|B-08594161371298 61 fields · synced 18 May 2026
  • EUDAMED 08594161370239|B-08594161370239 61 fields · synced 18 May 2026
  • EUDAMED 08594161370628|B-08594161370628 61 fields · synced 19 May 2026