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Ultra-Smt Anesthesia Mask, Size 1, Infant

by Besmed Health Business Corp.

Ref CM-65810

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-CM-65810W9 Basic UDI-DI D-CM-65810W9UDI-DIDate1 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-CM-65810W9 UDI-DI Date23 Oct 2017ListedStatusListed 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  • Withdrawn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
Ultra-Smt Infant Anaesthetic Face Mask #1 ; 15M
Generic Name
Anaesthesia face mask, single-use
Device Name
Ultra-Smt Anesthesia Mask, Size 1, Infant
Model / Reference
CM-65810
Primary DI / UDI-DI
D-CM-65810W9 EUDAMED
04716770658100 GUDID
Basic UDI-DI
B-CM-65810W9
FDA Product Code
BSJ
EMDN Code
R020199 Breathing circuits and kits - other
GMDN Term
Anaesthesia face mask, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5550
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-CM-65810W9
GUDID
04716770658100
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Besmed Health Business Corp.

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Properties

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

Other properties (16)

  • Sterile: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No