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Ostomy bag

by Hubei Ningkang Medical Technology Co., Ltd

Ref 1101Model 1101、1102、1103、1105、1106、1107、1108、1109、1110、1112、1113、1115、1116、1117、1118、1119、1120、1125、1126、1127、1128、1129、1130、1131、1132、1133、1134、etc

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697551874OB001JM Basic UDI-DI 06975518740004UDI-DIDate13 Jun 2025RegisteredStatusActive

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  • Withdrawn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 bag
Model / Reference
1101、1102、1103、1105、1106、1107、1108、1109、1110、1112、1113、1115、1116、1117、1118、1119、1120、1125、1126、1127、1128、1129、1130、1131、1132、1133、1134、etc, 1101
Primary DI / UDI-DI
06975518740004
Basic UDI-DI
697551874OB001JM
EMDN Code
A1001010101 One-piece colostomy bags for non-retracted stoma, flat, w/o tissue cover
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048145
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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