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Anorectal Drug Delivery Device

by Zhejiang Baihuo Health Technology Co., Ltd. 10 variants

Ref ZRS-P, WCM-P, ZCM, ZCS-P, Y-M, WRS-P, WCM, ZRS, Y-Ⅰ, ZCM-P, Y-Ⅲ, WRM, WCS

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 Number697525418AMA8Children5W Basic UDI-DI Date19 Sep 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  • Withdrawn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

Model / Reference
ZRS-P, WCM-P, ZCM, ZCS-P, Y-M, WRS-P, WCM, ZRS, Y-Ⅰ, ZCM-P, Y-Ⅲ, WRM, WCS
Primary DI / UDI-DI
06975254189518, 06975254187170, 06975254189136, 06975254189112, 06975254188030, 06975254187514, 06975254187132, 06975254189563, 06975254188016, 06975254189174, 06975254188139, 06975254187538, 06975254187163
Basic UDI-DI
697525418AMA8Children5W, 697525418AMA8AdultsT2, 697525418AMA8InfantsZ5
EMDN Code
G05 Topical anorectal administered gastro-intestinal system devices
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000049598
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Zhejiang Baihuo Health Technology Co., Ltd.

See all devices from Zhejiang Baihuo Health Technology Co., Ltd. →

Properties

  • Administering Medicine

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No