Skip to content

Flexima™ M001271570

by Boston Scientific

Ref M001271570

Flexima™ M001271570 is a device classified as Class IIb in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-08714729323198) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 08714729323198), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08714729323198 Basic UDI-DI 08714729323198UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729323198 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08714729323198 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 08714729323198 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729323198
  2. Registered EUDAMED B-08714729323198

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  • Withdrawn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
Flexima™
Generic name
Biliary drain
Device name
Flexima Biliary Drainage Catheters (Regular) - Class II LSLSI
Model / Ref / Catalog
M001271570
Primary DI / UDI-DI
08714729323198
Basic UDI-DI
B-08714729323198
FDA product code
FGE
EMDN code
A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
GMDN term
Biliary drain
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.5010
System or procedure pack
System which is a device in itself
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Biliary drain

Similar devices in this category

Other devices filed under EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS).

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)