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Disposable infection control barrier

by Minitube AB EUDAMEDGUDID

Active European Union

Ref 447501

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07350069421562 UDI-DIDate1 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++B9764000006K Basic UDI-DIDate15 Dec 2021RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
C20 Intraoral Protective Sheaths
Generic Name
Medical equipment/instrument drape, single-use
Device Name
Disposable infection control barrier
Model / Reference
447501 EUDAMED
403061 GUDID
Primary DI / UDI-DI
07350069421562
Basic UDI-DI
++B9764000006K
Unit of Use DI
07350069420565
510(k) Number
FDA Product Code
PEM
EMDN Code
T030102 Cover sheaths, instruments and equipments
GMDN Term
Medical equipment/instrument drape, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4370
Market of Registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
447501
GUDID
403061
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000002089

Other devices from Minitube AB

See all devices from Minitube AB →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No