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neocote

by Collagen Matrix, Inc.

Ref NEOCOTE

neocote is a device classified as Class III (EU), Unclassified (US) made by Collagen Matrix, Inc., registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI B-00813954022086) and listed in FDA GUDID since 21 Apr 2017 (UDI-DI 00813954022086), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813954022086 Basic UDI-DI 00813954022086UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813954022086 UDI-DI Date21 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00813954022086 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI 00813954022086 listed 21 Apr 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813954022086
  2. Registered EUDAMED B-00813954022086

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  • Withdrawn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

Generic name
General oral wound dressing, animal-derived
Model / reference
neocote
Primary DI / UDI-DI
00813954022086
Basic UDI-DI
B-00813954022086
FDA product code
KGN
EMDN code
Q010304 Periodontal dressings
GMDN term
General oral wound dressing, animal-derived
Device class
Class III EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 4 Centimeter
Width — 2 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
U
ImplantableEUDAMED
Yes
GUDID
No

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

Related devices

Category: General oral wound dressing, animal-derived

Similar devices in this category

Other devices filed under PERIODONTAL DRESSINGS.

Other devices from Collagen Matrix, Inc.

See all devices from Collagen Matrix, Inc. →

Properties

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