Skip to content

Silicone Infant Resuscitator 280ml W/ 40 cmH2O POP-OFF

by Besmed Health Business Corp.

Ref RE-24320

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-24320YM Basic UDI-DI D-RE-24320YMUDI-DIDate6 Jan 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-RE-24320YM UDI-DI Date15 Dec 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.

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  • Withdrawn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
Silicone Infant 280ml Resuscitator W/ Pop-Off 40cm H2O (All in One-Intake Valve
Generic Name
Pulmonary resuscitator, manual, reusable
Device Name
Silicone Infant Resuscitator 280ml W/ 40 cmH2O POP-OFF
Model / Reference
RE-24320
Primary DI / UDI-DI
D-RE-24320YM EUDAMED
04716770243207 GUDID
Basic UDI-DI
B-RE-24320YM
510(k) Number
FDA Product Code
BTM
EMDN Code
R03020201 Manually operated pulmonary resuscitators
GMDN Term
Pulmonary resuscitator, manual, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5915
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-RE-24320YM
GUDID
04716770243207
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

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

Other properties (18)

  • Sterile: No
  • Single Use: 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