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Acquire™ Pulmonary M00552350

by Boston Scientific

Ref M00552350

Acquire™ Pulmonary M00552350 is a device classified as Class IIa in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 31 Oct 2025 (Basic UDI-DI 01915060000000000000118MQ) and listed in FDA GUDID since 19 Apr 2019 (UDI-DI 08714729986225), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000118MQ Basic UDI-DI 08714729986225UDI-DIDate31 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729986225 UDI-DI Date19 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000118MQ registered 31 Oct 2025 Active
  • FDA GUDID UDI-DI 08714729986225 listed 19 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729986225
  2. Registered EUDAMED 01915060000000000000118MQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Acquire™ EUDAMED
Acquire™ Pulmonary GUDID
Generic name
Body aspiration needle, single-use
Device name
Ebus-Tban
Model / reference
M00552350
Primary DI / UDI-DI
08714729986225
Basic UDI-DI
01915060000000000000118MQ
FDA product code
EOQ, FCG
EMDN code
A010207 Pulmonary biopsy needles and kits
GMDN term
Body aspiration needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4680, 876.1075
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Body aspiration needle, single-use

Similar devices in this category

Other devices filed under BIOPSY NEEDLES AND KITS.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)