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Scopeye 3D Microvision

by MediThinQ. Co., Ltd.

Ref SE-MVS, SD-ED, SE-MV, SE-EDFModel ScopEYE

Scopeye 3D Microvision (SE-MVS) is a medical device (EU MDR Class I) made by MediThinQ Co., Ltd., registered in EUDAMED on 27 Mar 2026 (Basic UDI-DI 88001826SEMVSRL), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001826SEMVSRL Basic UDI-DI Date27 Mar 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade name
Scopeye 3D Microvision
ScopEYE
Device name
Se-Ed
Model / reference
SE-MVS, ScopEYE, SD-ED, SE-MV, SE-EDF
Primary DI / UDI-DI
88001826004614, 88001826001330, 88001826003938, 88001826004546
Basic UDI-DI
88001826SEMVSRL, 88001826METASCOPEM4, 88001826SEMVSK, 88001826SEEDFMU
EMDN code
Z12011101, Z12020406
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

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

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Properties

Other properties (14, all answered No)