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Ultraspec Screening Speculum Medium w/o Ratchet

by Robinson Healthcare Ltd 2 variants

Ref 9129

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5010058CInT047G00APE Basic UDI-DI 05010058091290UDI-DIDate12 Dec 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  • Withdrawn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
Non sterile speculums
Model / Reference
9129
Primary DI / UDI-DI
05010058091290
Basic UDI-DI
5010058CInT047G00APE
EMDN Code
U089006 Vaginal speculum, single-use
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000016546
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Robinson Healthcare Ltd

See all devices from Robinson Healthcare 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