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Silikon-Gastrostomie-Ersatz-Ballonsonde (Frachballon Type)

by Create Medic Co., Ltd. 5 variants

Ref EN800-000-2162R

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number45421870000893 Basic UDI-DI 04542187251692UDI-DIDate3 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
All Silicone Gastrostomy Balloon Catheter
Model / Reference
EN800-000-2162R
Primary DI / UDI-DI
04542187251692
Basic UDI-DI
45421870000893
EMDN Code
G02020201 Gastrostomy, tubes and sets
Device Class
Class IIb
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
JP-MF-000010849
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Create Medic Co., Ltd.

See all devices from Create Medic Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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