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A36B000

by Ophthalmed LLC

Ref A36B000

A36B000 is an ophthalmic laser system beam guide (EU MDD Class IIa; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Ophthalmed LLC, registered in EUDAMED on 12 Mar 2026 (Basic UDI-DI B-00811682030991), cleared under FDA 510(k) K021696 on 20 Aug 2002 and listed in FDA GUDID since 9 Feb 2018 (UDI-DI 00811682030991), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K021696

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00811682030991 Basic UDI-DI 00811682030991UDI-DIDate12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00811682030991 UDI-DI Date9 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK021696 Date20 Aug 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00811682030991 registered 12 Mar 2026 Active
  • FDA 510(k) K021696 decided 20 Aug 2002 Active
  • FDA GUDID UDI-DI 00811682030991 listed 9 Feb 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K021696
  2. Listed FDA GUDID 00811682030991
  3. Registered EUDAMED B-00811682030991

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Ophthalmed® laser probe
Generic name
Ophthalmic laser system beam guide
Device name
LASER PROBE 25g CURVED TIP WITH LASER LIGHTMED
Model / reference
A36B000
Primary DI / UDI-DI
00811682030991 EUDAMED
M735A36B0001 GUDID
Basic UDI-DI
B-00811682030991
510(k) Number
FDA product code
GEX
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
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 25 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00811682030991
GUDID
M735A36B0001
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00811682030991; FDA GUDID lists M735A36B0001), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ophthalmic laser system beam guide

Cleared under the same submission (K021696)

and 8 more cleared under K021696

Similar devices in this category

Other devices filed under OCULAR ENDOPHOTOCOAGULATION FIBERS, SINGLE-USE.

Other devices from Ophthalmed LLC

  • Ophthalmed® laser probe

    Class IIa

  • B577304

    Class II

  • B567105

    Class II

  • B507305

    Class II

See all devices from Ophthalmed LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)