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NK Loupe

by Medipia-Laa

Ref 17.NKvision_Catalog_Medipia_2025Model TTL Loupe x2.5 NK00 / TTL Loupe x2.5 NK01 TTL Loupe x3.0 NK00 / TTL Loupe x3.0 NK01 TTL Loupe x3.3 NK00 / TTL Loupe x3.3 NK01 TTL Loupe x3.8 NK00 / TTL Loupe x3.8 NK01 TTL Loupe x5.0 NK00 / TTL Loupe x5.0 NK01 TTL Loupe x6.0 NK00 / TTL Loupe x6.0 NK01

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88099060NKTTLLOUPE5V Basic UDI-DI Date30 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
NK Loupe
Model / Reference
TTL Loupe x2.5 NK00 / TTL Loupe x2.5 NK01 TTL Loupe x3.0 NK00 / TTL Loupe x3.0 NK01 TTL Loupe x3.3 NK00 / TTL Loupe x3.3 NK01 TTL Loupe x3.8 NK00 / TTL Loupe x3.8 NK01 TTL Loupe x5.0 NK00 / TTL Loupe x5.0 NK01 TTL Loupe x6.0 NK00 / TTL Loupe x6.0 NK01, 17.NKvision_Catalog_Medipia_2025
Primary DI / UDI-DI
08809906010029, 08809906010005
Basic UDI-DI
88099060NKTTLLOUPE5V
EMDN Code
L0316 Helmets and binocular glasses for surgeons
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000039665
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Medipia-Laa

Properties

Other properties (13)

  • Sterile: No
  • 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