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ClearField Pro, Slate Ring VCFPRO-SE

by Volk Optical Inc.

Ref VCFPRO-SE

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
United StatesGUDID listing GUDID Number00715003000024 UDI-DI Date28 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number81160801BIOSE Basic UDI-DI 00715003000024UDI-DIDate5 Feb 2026RegisteredStatusActive

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  • Withdrawn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
ClearField Pro, Slate Ring
Generic Name
Ophthalmic diagnostic condensing lens
Device Name
Binocular Indirect Ophthalmoscope (BIO) Lens
Model / Reference
VCFPRO-SE
Primary DI / UDI-DI
00715003000024
Basic UDI-DI
81160801BIOSE
Direct Marketing DI
00715003000024
FDA Product Code
HJL
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
GMDN Term
Ophthalmic diagnostic condensing lens
Device Class
Class I
Regulation Number
886.1380
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Other devices from Volk Optical Inc.

See all devices from Volk Optical Inc. →

Properties

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