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Pentax Prismvue NF2 T30S(K)

by HOYA Technosurgical Corporation

Ref 2037906

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4582428-TSU-0001QW Basic UDI-DI 04582428448016UDI-DIDate26 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
PENTAX Surgical Loupes
Model / Reference
2037906
Primary DI / UDI-DI
04582428448016
Basic UDI-DI
4582428-TSU-0001QW
EMDN Code
L0316 Helmets and binocular glasses for surgeons
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
JP-MF-000045863
Authorised representative
HOYA Holdings B.V. NL-AR-000004416

Other devices from HOYA Technosurgical Corporation

See all devices from HOYA Technosurgical Corporation →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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