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Disposable Pressure Manometer, 0-60 cm H2O

by Mercury Medical Enterprises, LLC 18 variants

Ref 10-55358Model 10-55350

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

CE MDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0641043MAMT Basic UDI-DIDate19 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10641043553589 UDI-DIDate15 Apr 2018ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Manometer
Generic Name
Airway pressure monitor, non-powered
Device Name
Disposable Pressure Manometer, 0-60 cm H2O
Model / Reference
10-55350, 10-55358
Primary DI / UDI-DI
10641043553589
Basic UDI-DI
0641043MAMT
510(k) Number
FDA Product Code
CAP
EMDN Code
R028099 Respiratory circuits and mount catheters - accessories not included in other classes
GMDN Term
Airway pressure monitor, non-powered
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.2600
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
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
  • Measuring Function
  • 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
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No