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Classic-Cuf Iso, Adult, Dinaclick, 23 - 33 Cm, 80369-5, Single

by GE Medical Systems Information Technologies, Inc.

Ref 5855282

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

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 Number8406821BUG00035GX Basic UDI-DI 00195278025296UDI-DIDate7 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278025296 UDI-DI Date2 Aug 2021ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Classic-Cuf Iso, Adult, Dinaclick, 23 - 33 Cm, 80369-5, Single EUDAMED
Classic-Cuf GUDID
Generic Name
Blood pressure cuff, reusable
Device Name
Classic-Cuf Non-Invasive Blood Pressure Cuff
Model / Ref / Catalog
5855282 EUDAMED
CLA-A2-2A-X-5S GUDID
Primary DI / UDI-DI
00195278025296
Basic UDI-DI
8406821BUG00035GX
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
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5855282
GUDID
CLA-A2-2A-X-5S
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

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

Other properties (20)

  • 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
  • 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