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Soft-Cuf, Infant, 1 Tb Bayonet, 08 - 13 Cm, Single

by GE Medical Systems Information Technologies, Inc.

Ref 2054883-143

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

CE MDR

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/MDR EUDAMED Number8406821BUG00034GV Basic UDI-DI 00840682106610UDI-DIDate6 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682106610 UDI-DI Date30 Jun 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Soft-Cuf, Infant, 1 Tb Bayonet, 08 - 13 Cm, Single EUDAMED
Soft-Cuf GUDID
Generic Name
Blood pressure cuff, reusable
Device Name
Soft-Cuf Non-Invasive Blood Pressure Cuff
Model / Ref / Catalog
2054883-143 EUDAMED
2360 GUDID
Primary DI / UDI-DI
00840682106610
Basic UDI-DI
8406821BUG00034GV
510(k) Number
FDA Product Code
DXQ
EMDN Code
Z12040180 General medicine diagnosis and monitoring instruments - hardware accessories
GMDN Term
Blood pressure cuff, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1120
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
2054883-143
GUDID
2360
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017529
Authorised representative
GE Medical Systems SCS FR-AR-000000344

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • 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
  • Expiration Date: No