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BETA X Retinoscope 000

by Heine Optotechnik GmbH & Co. KG

Ref C-140.28.330

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4053755_RS-S_07_SZ Basic UDI-DI 04053755213931UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053755213931 UDI-DI Date3 Sep 2026ListedStatusListed 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  • Withdrawn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
BETA X Retinoscope
Generic Name
Retinoscope, battery-powered
Model / Ref / Catalog
C-140.28.330, 000
Primary DI / UDI-DI
04053755213931
Basic UDI-DI
4053755_RS-S_07_SZ
FDA Product Code
HKM
EMDN Code
Z12120118 Retinoscopes
GMDN Term
Retinoscope, battery-powered
Device Class
Class I
Regulation Number
886.1780
Medical Purpose
This is a collection of devices intended for use by physicians to help them perform eye examinations on patients.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
C-140.28.330
GUDID
000

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Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No