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Na B507305

by Ophthalmed LLC

Ref B507305

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00811682036092 Basic UDI-DI 00811682036092UDI-DIDate12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00811682036092 UDI-DI Date6 Aug 2022ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ophthalmed® laser probe
Generic Name
Ophthalmic laser system beam guide
Device Name
ILLUMINATED LASER PROBE 27g BENDING TIP WITH LASER ALCON® AND ILLUMINATION ALCON® OCUTOME
Model / Reference
B507305
Primary DI / UDI-DI
00811682036092 EUDAMED
M735B5073051 GUDID
Basic UDI-DI
B-00811682036092
510(k) Number
FDA Product Code
HQB
EMDN Code
Q02040301 Ocular endophotocoagulation fibers, single-use
GMDN Term
Ophthalmic laser system beam guide
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.4690
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 27 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00811682036092
GUDID
M735B5073051
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Ophthalmic laser system beam guide

Cleared under the same submission (K142830)

Other devices from Ophthalmed LLC

See all devices from Ophthalmed LLC →

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