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Urinary Sheath

by Housen Medical lndustrial Co., Ltd 65 variants

Ref STANDARD(Non-Adhesive)33, POPON(Extra-Gluing)32, MIDI(Non-Adhesive)32, MIDI18, STANDARD32, POPON32, STANDARD28, POPON33, STANDARD24, MIDI20, STANDARD(Non-Adhesive)31, STANDARD(Non-Adhesive)20, MIDI40, MIDI(Non-Adhesive)28, POPON(Non-Adhesive)28, STANDARD31, POPON(Non-Adhesive)29, MIDI(Extra-Gluing)24, MIDI(Non-Adhesive)25, STANDARD(Extra-Gluing)18, STANDARD(Non-Adhesive)18, MIDI(Extra-Gluing)20, WIDEBAND20, WIDEBAND41, POPON28, MIDI32, MIDI(Extra-Gluing)25, POPON(Non-Adhesive)31, STANDARD(Extra-Gluing)29, STANDARD40, POPON(Non-Adhesive)40, MIDI25, STANDARD29, MIDI29, MIDI(Extra-Gluing)33, POPON40, WIDEBAND(Extra-Gluing)28, WIDEBAND28, MIDI(Extra-Gluing)30, STANDARD25, MIDI(Non-Adhesive)41, WIDEBAND(Extra-Gluing)35, POPON(Extra-Gluing)20, POPON(Non-Adhesive)35, MIDI(Extra-Gluing)18, STANDARD18, STANDARD(Extra-Gluing)25, WIDEBAND(Extra-Gluing)30, POPON(Non-Adhesive)24, MIDI(Extra-Gluing)41, WIDEBAND30Model STANDARD18, STANDARD20, STANDARD24, STANDARD25, STANDARD28, STANDARD29, STANDARD30, STANDARD31, STANDARD32, STANDARD33, STANDARD35, STANDARD36, STANDARD40, STANDARD41,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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697687808US001WB Basic UDI-DI Date31 Jul 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  • Withdrawn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
Urinary Sheath
Model / Reference
STANDARD18, STANDARD20, STANDARD24, STANDARD25, STANDARD28, STANDARD29, STANDARD30, STANDARD31, STANDARD32, STANDARD33, STANDARD35, STANDARD36, STANDARD40, STANDARD41, etc., STANDARD(Non-Adhesive)33, POPON(Extra-Gluing)32, MIDI(Non-Adhesive)32, MIDI18, POPON32, POPON33, MIDI20, STANDARD(Non-Adhesive)31, STANDARD(Non-Adhesive)20, MIDI40, MIDI(Non-Adhesive)28, POPON(Non-Adhesive)28, POPON(Non-Adhesive)29, MIDI(Extra-Gluing)24, MIDI(Non-Adhesive)25, STANDARD(Extra-Gluing)18, STANDARD(Non-Adhesive)18, MIDI(Extra-Gluing)20, WIDEBAND20, WIDEBAND41, POPON28, MIDI32, MIDI(Extra-Gluing)25, POPON(Non-Adhesive)31, STANDARD(Extra-Gluing)29, POPON(Non-Adhesive)40, MIDI25, MIDI29, MIDI(Extra-Gluing)33, POPON40, WIDEBAND(Extra-Gluing)28, WIDEBAND28, MIDI(Extra-Gluing)30, MIDI(Non-Adhesive)41, WIDEBAND(Extra-Gluing)35, POPON(Extra-Gluing)20, POPON(Non-Adhesive)35, MIDI(Extra-Gluing)18, STANDARD(Extra-Gluing)25, WIDEBAND(Extra-Gluing)30, POPON(Non-Adhesive)24, MIDI(Extra-Gluing)41, WIDEBAND30
Primary DI / UDI-DI
06976878080526, 06976878080939, 06976878081356, 06976878081134, 06976878080090, 06976878080236, 06976878080052, 06976878080243, 06976878080038, 06976878081141, 06976878080502, 06976878080441, 06976878081257, 06976878081318, 06976878080755, 06976878080083, 06976878080762, 06976878081431, 06976878081301, 06976878080571, 06976878080434, 06976878081424, 06976878080304, 06976878080427, 06976878080199, 06976878081219, 06976878081448, 06976878080786, 06976878080625, 06976878080137, 06976878080830, 06976878081165, 06976878080069, 06976878081189, 06976878081509, 06976878080274, 06976878081035, 06976878080335, 06976878081479, 06976878080045, 06976878081400, 06976878081097, 06976878080861, 06976878080816, 06976878081417, 06976878080014, 06976878080601, 06976878081059, 06976878080731, 06976878081547, 06976878080359
Basic UDI-DI
697687808US001WB
EMDN Code
A06030301 Urine collection bags
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048899
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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