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FlexiPort EcoCuff

by Welch Allyn, Inc. 4 variants

Ref ECOCUFF-12Model 901045

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901045F4 Basic UDI-DI 00732094236972UDI-DIDate18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00732094236972 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: 1 of 2 UDI-DIs 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  • Withdrawn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
FlexiPort EcoCuff EUDAMED
Welch Allyn, Inc. GUDID
Generic Name
Blood pressure cuff, reusable
Model / Ref / Catalog
901045, ECOCUFF-12, ECOCUFF-12ILB
Description
Welch Allyn FlexiPort ECO Blood Pressure Cuff; Size-12 Large Adult, Single-Patient Use, No Tubes or Connectors; Qty. 100
ECO CUFF LARGE ADULT BOX OF 50
Primary DI / UDI-DI
00732094236972, 00732094177381
Basic UDI-DI
0732094GMN901045F4
Unit of Use DI
00732094203967
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
Ireland
GUDID distribution status
Not in Commercial Distribution (UDI-DI 00732094177381)
In Commercial Distribution (UDI-DI 00732094236972)

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000013394
Authorised representative
Welch Allyn Limited IE-AR-000000768

Other devices from Welch Allyn, Inc.

See all devices from Welch Allyn, Inc. →

Properties

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

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