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Mach1™ M001198620

by Boston Scientific

Ref M001198620

Mach1™ M001198620 is a device classified as Class IIa in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-08714729404101) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08714729404101), active as of 7 Nov 2026.

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

CE MDD

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/MDD EUDAMED NumberB-08714729404101 Basic UDI-DI 08714729404101UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729404101 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08714729404101 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 08714729404101 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729404101
  2. Registered EUDAMED B-08714729404101

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Mach1™
Generic name
Vascular guide-catheter, single-use
Device name
Mach1
Model / reference
M001198620
Primary DI / UDI-DI
08714729404101
Basic UDI-DI
B-08714729404101
FDA product code
DQY
EMDN code
C0104020204 Peripheral angiography guide catheters
GMDN term
Vascular guide-catheter, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1250
EU registration type
Legacy device (under a directive)
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: Vascular guide-catheter, single-use

Similar devices in this category

Other devices filed under PERIPHERAL ANGIOGRAPHY THERAPEUTIC DEVICES.

Other devices from Boston Scientific

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)