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Disposable Manual Resuscitator

by Mercury Medical Enterprises, LLC EUDAMEDGUDID

Active European Union

Ref 10-56222Model 10-55000

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0641043CPMT Basic UDI-DIDate21 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10641043562222 UDI-DIDate24 Oct 2015ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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

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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Disposable Manual Resuscitator EUDAMED
CPR-2 Bag GUDID
Generic Name
Pulmonary resuscitator, manual, single-use
Device Name
Adult CPR Bag
Model / Reference
10-55000, 10-56222
Primary DI / UDI-DI
10641043562222
Basic UDI-DI
0641043CPMT
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
Market of Registration
Netherlands
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
US-MF-000002015
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Mercury Medical Enterprises, LLC

See all devices from Mercury Medical Enterprises, LLC →

Properties

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

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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