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Aural Speculum Oval/Bevelled, Set of 3 (ASS, AS6, AS7)

by Exmoor Plastics Limited

Ref AS8

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060180255787 Basic UDI-DI 05060180255787UDI-DIDate24 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060180255787 UDI-DI Date17 Sep 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Aural Speculum Oval/Bevelled, Set of 3 (ASS, AS6, AS7) EUDAMED
Exmoor GUDID
Generic Name
Ear speculum, single-use
Device Name
Exmoor Aural Specula
Model / Ref / Catalog
AS8
Primary DI / UDI-DI
05060180255787
Basic UDI-DI
B-05060180255787
FDA Product Code
EPY
EMDN Code
Q03040101 Ear drainage and ventilation catheters and cannulas
GMDN Term
Ear speculum, single-use
Device Class
Class I
Regulation Number
878.1800
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GB-MF-000025513
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Exmoor Plastics Limited

See all devices from Exmoor Plastics Limited →

Properties

  • Sterile
  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No