Skip to content

Optomic OP-2000 HD Camera

by Optomic España SA

Ref 53423237

Optomic OP-2000 HD Camera is an endoscope video camera (EU MDR Class I; FDA Class I; FDA product code FWD, Camera, Television, Microsurgical, Without Audio) made by Optomic España SA, registered in EUDAMED on 11 Nov 2024 (Basic UDI-DI 84360415807233G) and listed in FDA GUDID since 17 Jul 2024 (UDI-DI 08436041580294), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number84360415807233G Basic UDI-DI 08436041580294UDI-DIDate11 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08436041580294 UDI-DI Date17 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 84360415807233G registered 11 Nov 2024 Active
  • FDA GUDID UDI-DI 08436041580294 listed 17 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08436041580294
  2. Registered EUDAMED 84360415807233G

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  • Withdrawn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
Op-2000 Hd EUDAMED
Optomic GUDID
Generic name
Endoscope video camera
Device name
Camera
Model / reference
53423237 EUDAMED
OP-2000 HD Camera GUDID
Primary DI / UDI-DI
08436041580294
Basic UDI-DI
84360415807233G
FDA product code
FWD
EMDN code
Z12020405 Surgical cameras
GMDN term
Endoscope video camera
Device class
Class I
Regulation number
878.4160
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
53423237
GUDID
OP-2000 HD Camera

Related devices

Category: Endoscope video camera

Similar devices in this category

Other devices filed under SURGICAL CAMERAS.

Other devices from Optomic España SA

See all devices from Optomic España SA →

Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)