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Ostomy Bag

by Xinxiang City Rongjun Medical Apparatus Co, Ltd.

Ref OP-C-CL-38-OModel OP-C-CL-38-O,OP-C-CL-38-F,OP-C-CL-45-O,OP-C-CL-45-F,OP-C-CL-57-O,OP-C-CL-57-F,OP-C-CL-70-O, 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 Number697394987OstomyBagZQ Basic UDI-DIDate23 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
OP-C-CL-38-O, OP-C-CL-38-F, OP-C-CL-45-O, OP-C-CL-45-F, OP-C-CL-57-O, OP-C-CL-57-F, OP-C-CL-70-O, etc.
Primary DI / UDI-DI
06973949872202
Basic UDI-DI
697394987OstomyBagZQ
EMDN Code
A1099 Abdominal ostomy devices - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057262
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xinxiang City Rongjun Medical Apparatus 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