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Welch Allyn

by Welch Allyn, Inc. 65 variants

Ref 12880-BLKModel 901082

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901082FA Basic UDI-DI 00732094195989UDI-DIDate3 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00732094195989 UDI-DI Date17 Sep 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.

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  • Withdrawn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
Ophthalmic/otologic diagnostic set
Model / Ref / Catalog
901082, 12880-BLK, 410286
Description
POCKETPLUS LED OPH HEAD AND HNDL BLACK
Primary DI / UDI-DI
00732094195989, 00732094204193
Basic UDI-DI
0732094GMN901082FA
FDA Product Code
ERA
EMDN Code
Z12120114 Ophthalmoscopes
GMDN Term
Ophthalmic/otologic diagnostic set
Device Class
Class I
Regulation Number
874.4770
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

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
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (20)

  • 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
  • Serial Number: No
  • Expiration Date: No