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Single Use Adult 1600ml Resuscitator W/ Pop-Off 60 CMH2O (All in One-Intake Valve)

by Besmed Health Business Corp.

Ref RE-23420, RE-24437

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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-RE-23420YK Basic UDI-DI Date6 Jan 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-RE-23420YK UDI-DI Date23 May 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Single use resuscitator 1600 ml W/ 60 cmH2O POP-OFF (W/O MDI port), Oxygen tubing (2.0 m), Air cushion mask (size 5), Oxygen reservoir (2500 ml), Adult EUDAMED
Single Use Adult 1700ml Resuscitator W/ Pop-Off 60cm H2O GUDID
SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF, 60cm H2O & MANOMETER PORT GUDID
Generic Name
Pulmonary resuscitator, manual, single-use
Device Name
Single Use Adult 1600ml Resuscitator W/ Pop-Off 60 CMH2O (All in One-Intake Valve)
Model / Reference
RE-23420, RE-24437
Primary DI / UDI-DI
D-RE-23420YK, 04716770244372, 04716770234205
Basic UDI-DI
B-RE-23420YK, B-04716770244372
510(k) Number
FDA Product Code
BTM
EMDN Code
R03020201 Manually operated pulmonary resuscitators
GMDN Term
Pulmonary resuscitator, manual, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5915
EU market of registration
Germany
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Related devices

Category: Pulmonary resuscitator, manual, single-use

Other devices from Besmed Health Business Corp.

See all devices from Besmed Health Business Corp. →

Properties

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

Other properties (17)

  • 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
  • Premarket Exempt: No
  • Serial Number: No