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OCUTECH® VES®-Sport II 5x BIOPTIC TELESCOPE SYSTEM

by Ocutech, Inc.

Ref A5205Model Keplerian Optical Devices

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 Number0850008829KeplerianLVC3 Basic UDI-DI 00850008829628UDI-DIDate22 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00850008829628 UDI-DI Date1 Apr 2020ListedStatusListed 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  • Withdrawn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
OCUTECH® VES®-Sport II 5x BIOPTIC TELESCOPE SYSTEM EUDAMED
Ocutech GUDID
Generic Name
Spectacle-mounted telescope
Model / Ref / Catalog
Keplerian Optical Devices, A5205, VES Sp II 5x TS
Primary DI / UDI-DI
00850008829628
Basic UDI-DI
0850008829KeplerianLVC3
FDA Product Code
HKK
EMDN Code
Y210321 Far sightedness telescopic systems/spectacles
GMDN Term
Spectacle-mounted telescope
Device Class
Class I
Regulation Number
886.5870
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Keplerian Optical Devices
A5205
GUDID
VES Sp II 5x TS

Manufacturer details

EUDAMED SRN
US-MF-000047026
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Ocutech, Inc.

See all devices from Ocutech, Inc. →

Properties

  • Premarket Exempt

Other properties (23)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No