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Acuity™ 7060

by Boston Scientific 2 variants

Ref 7060

Acuity™ 7060 is a device classified as Class I in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 01915060000000000000388NP) and listed in FDA GUDID since 15 Oct 2026 (UDI-DI 00802526625008), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000388NP Basic UDI-DI 00802526625008UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00802526625008 UDI-DI Date15 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000388NP registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00802526625008 listed 15 Oct 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00802526625008
  2. Registered EUDAMED 01915060000000000000388NP

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  • Withdrawn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
Acuity™
Generic name
Intravascular catheter slitter
Device name
Acuity™ Universal Cutter
Model / Ref / Catalog
7060
Primary DI / UDI-DI
00802526625008
Basic UDI-DI
01915060000000000000388NP
FDA product code
DQY
EMDN code
C01040180 Coronary angiography devices - accessories not included in other classes
GMDN term
Intravascular catheter slitter
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1250
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 I
GUDID
Class II

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

Similar devices in this category

Other devices filed under CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (19, all answered No)