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Flexima™ M001271870

by Boston Scientific

Ref M001271870

Flexima™ M001271870 is a device classified as Class IIb in the EU and Class I in the US made by Boston Scientific, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-08714729323389) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08714729323389), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08714729323389 Basic UDI-DI 08714729323389UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729323389 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08714729323389 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 08714729323389 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729323389
  2. Registered EUDAMED B-08714729323389

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  • Withdrawn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
Nephrostomy catheter
Device name
Nephrostomy Drainage Catheter Configurations
Model / reference
M001271870
Primary DI / UDI-DI
08714729323389
Basic UDI-DI
B-08714729323389
FDA product code
GBO
EMDN code
U040202 Nephrostomy kits, seldinger method
GMDN term
Nephrostomy catheter
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
878.4200
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

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

Related devices

Category: Nephrostomy catheter

Similar devices in this category

Other devices filed under DEVICES FOR PERCUTANEOUS NEPHROSTOMY.

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Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)