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Ostomy Bags

by JM Medical Co., Ltd.

Ref Type A (A001)Model Type A (A001), Type A (A001-6), Type A (A002), Type A (A002-1), Type A (A003), Type A (A003-8), Type A (A005), Type A (A005), Type C (C001), E001, E002-T, B0345, B0345-2, FB0345-1, B0645-3, D003, B0460, B041, B021, B021-1, Custom-made.

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697407780OB001FR Basic UDI-DI 06974077802000UDI-DIDate1 Aug 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Ostomy Bags
Model / Reference
Type A (A001), Type A (A001-6), Type A (A002), Type A (A002-1), Type A (A003), Type A (A003-8), Type A (A005), Type C (C001), E001, E002-T, B0345, B0345-2, FB0345-1, B0645-3, D003, B0460, B041, B021, B021-1, Custom-made.
Primary DI / UDI-DI
06974077802000
Basic UDI-DI
697407780OB001FR
EMDN Code
A100199 Devices for abdominal ostomy - one piece - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042779
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from JM Medical Co., Ltd.

See all devices from JM Medical Co., Ltd. →

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