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Anesthesia Face Mask Pre-Filled Inflatable Single-Use Extra Large Adult Size 6 2106570-018

by Flexicare Medical Limited EUDAMEDGUDID

Active European Union

Ref 2106570-018

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788777274 Basic UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788777274 UDI-DIDate17 Jun 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Extra Large Adult Size 6
Generic Name
Anaesthesia face mask, single-use
Device Name
Anaesthesia Facemasks
Model / Reference
2106570-018
Primary DI / UDI-DI
05055788777274
Basic UDI-DI
B-05055788777274
FDA Product Code
BSJ
EMDN Code
R03010101 Anaesthetic face masks
GMDN Term
Anaesthesia face mask, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5550
Market of Registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Anaesthesia face mask, single-use

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No