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NeuroFlex CNCF2525

by Collagen Matrix, Inc.

Ref CNCF2525

NeuroFlex CNCF2525 is a device classified as Class III in the EU and Class II in the US made by Collagen Matrix, Inc., registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-00813954020075), cleared under FDA 510(k) K131541 on 3 Apr 2014 and listed in FDA GUDID since 16 Sep 2015 (UDI-DI 00813954020075), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131541

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813954020075 Basic UDI-DI 00813954020075UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813954020075 UDI-DI Date16 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131541 Date3 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00813954020075 registered 24 Jun 2026 Active
  • FDA 510(k) K131541 decided 3 Apr 2014 Active
  • FDA GUDID UDI-DI 00813954020075 listed 16 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131541
  2. Listed FDA GUDID 00813954020075
  3. Registered EUDAMED B-00813954020075

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
NeuroFlex™ EUDAMED
NeuroFlex GUDID
Generic name
Nerve guide, animal-derived
Device name
Collagen Nerve Cuff Flexible
Model / reference
CNCF2525
Primary DI / UDI-DI
00813954020075
Basic UDI-DI
B-00813954020075
FDA product code
JXI
EMDN code
N0199 Encephalic and peripheral nervous system devices - other
GMDN term
Nerve guide, animal-derived
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5275
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 2.5 Centimeter
Lumen/Inner Diameter — 2.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Nerve guide, animal-derived

Cleared under the same submission (K131541)

and 7 more cleared under K131541

Similar devices in this category

Other devices filed under ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER.

Other devices from Collagen Matrix, Inc.

See all devices from Collagen Matrix, Inc. →

Properties

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