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Single-use Fine Needle Biopsy (FNB) Device NA-U210H NA-U210H-8019

by Olympus Medical Systems Corp. 2 variants

Ref N6221150

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 Number495317000191BR Basic UDI-DI 04953170459368UDI-DIDate15 Sep 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  • Withdrawn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
Throat Microphone
Model / Reference
N6221150
Primary DI / UDI-DI
04953170459368
Basic UDI-DI
495317000191BR
EMDN Code
A01020102 Aspiration fine needles and kits
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000008016
Authorised representative
Olympus Europa SE & Co. KG DE-AR-000006774

Other devices from Olympus Medical Systems Corp.

See all devices from Olympus Medical Systems Corp. →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No