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Welch Allyn

by Welch Allyn, Inc. 65 variants

Ref 7000-APMModel 901011

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

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 Number0732094GMN901011AN6 Basic UDI-DI 00732094210613UDI-DIDate21 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00732094210613 UDI-DI Date10 Dec 2024ListedStatusListed 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

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1565-2025 FDA Class II initiated 21 Mar 2025
    • Ongoing Z-1564-2025 FDA Class II initiated 21 Mar 2025 on shared 510(k) K142356

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

    • Ongoing Z-2581-2023 FDA Class II initiated 10 Aug 2023

    Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Welch Allyn EUDAMED
Welch Allyn, Inc. GUDID
Generic Name
Multiple physiological parameter spot-check system, clinical
Model / Ref / Catalog
901011, 7000-APM, 901001
Primary DI / UDI-DI
00732094210613
Basic UDI-DI
0732094GMN901011AN6
510(k) Number
FDA Product Code
MWI
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Multiple physiological parameter spot-check system, clinical
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2300
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
901011
7000-APM
GUDID
901001
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

  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No