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ACE Ultra HD EBUS FNA Needle, 25 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Bronchoscope

by Ace Medical Devices Pvt Ltd

Ref AEBUS-FNA-25-PModel EBUS Needle (Ultra HD Variant) _AEBUS-FNA-25-P

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904148105486 Basic UDI-DI 08904148105486UDI-DIDate15 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Ultra HD EBUS FNA Needle, 25 G, 2.0 mm, 0-5 cm, 4.1 Fr, Compatible with Pentax Brand Bronchoscope
Model / Reference
EBUS Needle (Ultra HD Variant) _AEBUS-FNA-25-P, AEBUS-FNA-25-P
Primary DI / UDI-DI
08904148105486
Basic UDI-DI
B-08904148105486
EMDN Code
A01020102 Aspiration fine needles and kits
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
IN-MF-000023786
Authorised representative
Advena Limited MT-AR-000000234

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Properties

  • Sterile

Other properties (10)

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