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Scopeye

by MediThinQ. Co., Ltd. 3 variants

Ref SE-EDNH

Scopeye (SE-EDNH) is an endoscopic video image processing unit (EU MDR Class I; FDA Class I; FDA product code FEM, Accessories, Photographic, For Endoscope (Exclude Light Sources)) made by MediThinQ Co., Ltd., registered in EUDAMED on 12 Sep 2024 (Basic UDI-DI 88001826SEEDNHLV) and listed in FDA GUDID since 16 Feb 2024 (UDI-DI 88001826003556), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88001826SEEDNHLV Basic UDI-DI 88001826003556UDI-DIDate12 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number88001826003556 UDI-DI Date16 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88001826SEEDNHLV registered 12 Sep 2024 Active
  • FDA GUDID UDI-DI 88001826003556 listed 16 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 88001826003556
  2. Registered EUDAMED 88001826SEEDNHLV

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  • Withdrawn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

Generic name
Endoscopic video image processing unit
Model / reference
SE-EDNH
Primary DI / UDI-DI
88001826003556 EUDAMED
08800182600355 GUDID
Basic UDI-DI
88001826SEEDNHLV
FDA product code
FEM
EMDN code
Z12020406 Video processors
GMDN term
Endoscopic video image processing unit
Device class
Class I
Regulation number
876.1500
System or procedure pack
System which is a device in itself
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
Primary DI / UDI-DIEUDAMED
88001826003556
GUDID
08800182600355

The registries describe this device under different primary UDI-DIs (EUDAMED lists 88001826003556; FDA GUDID lists 08800182600355), so their flags are not compared.

Manufacturer details

EUDAMED SRN
KR-MF-000021424
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

Other devices from MediThinQ Co., Ltd.

See all devices from MediThinQ Co., Ltd. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)