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OpClear Platform

by Cipher Surgical Limited. 6 variants

Ref CS-10-00-330Model CU3DI3

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506034680CU3DI3Y5 Basic UDI-DI 50603468009988UDI-DIDate30 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number50603468009988 UDI-DI Date1 Oct 2021ListedStatusListed 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  • Withdrawn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
CS-10-00-330 OpClear Disposable
Generic Name
Endoscope lens cleaner, gas/fluid, single-use
Device Name
OpClear Platform
Model / Ref / Catalog
CU3DI3, CS-10-00-330
Primary DI / UDI-DI
50603468009988 EUDAMED
50603468008752 GUDID
Basic UDI-DI
506034680CU3DI3Y5
Unit of Use DI
50603468008752
FDA Product Code
FEQ, OCX
EMDN Code
Z12029015 Lens cleaning units
GMDN Term
Endoscope lens cleaner, gas/fluid, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
50603468009988
GUDID
50603468008752
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000008065
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Cipher Surgical, Ltd.

See all devices from Cipher Surgical, Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Serial Number: No
  • Manufacturing Date: No