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Flex- C15

by Boston Scientific Neuromodulation

Ref FLEX-C15

Flex- C15 is a device classified as Class IIb in the EU and Class II in the US made by Boston Scientific Neuromodulation, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 01915060000000000000503MX) and listed in FDA GUDID since 18 Dec 2017 (UDI-DI 00813250013368), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000503MX Basic UDI-DI 00813250013368UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813250013368 UDI-DI Date18 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000503MX registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 00813250013368 listed 18 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813250013368
  2. Registered EUDAMED 01915060000000000000503MX

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  • Withdrawn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
Flextrode™
Generic name
Radio-frequency ablation system
Device name
Non-CNS Electrode (Disposable)
Model / reference
FLEX-C15 EUDAMED
FLEX- C15 GUDID
Primary DI / UDI-DI
00813250013368
Basic UDI-DI
01915060000000000000503MX
FDA product code
GXD, GXI
EMDN code
K02030106 Radiofrequency surgery cannulas, single-use
GMDN term
Radio-frequency ablation system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4400, 882.4725
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FLEX-C15
GUDID
FLEX- C15
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: Radio-frequency ablation system

Similar devices in this category

Other devices filed under RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Boston Scientific Neuromodulation

See all devices from Boston Scientific Neuromodulation →

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)