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Neomem FlexPlus NF2030

by Collagen Matrix, Inc.

Ref NF2030

Neomem FlexPlus NF2030 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 29 Jun 2026 (Basic UDI-DI B-00813954021393) and listed in FDA GUDID since 24 Jan 2017 (UDI-DI 00813954021393), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813954021393 Basic UDI-DI 00813954021393UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813954021393 UDI-DI Date24 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00813954021393 registered 29 Jun 2026 Active
  • FDA GUDID UDI-DI 00813954021393 listed 24 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813954021393
  2. Registered EUDAMED B-00813954021393

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  • Withdrawn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
Neomem® FLEXPLUS EUDAMED
Neomem FlexPlus GUDID
Generic name
Collagen dental regeneration membrane
Device name
Collagen Dental Membrane - Porcine Peritoneum
Model / reference
NF2030
Primary DI / UDI-DI
00813954021393
Basic UDI-DI
B-00813954021393
FDA product code
NPL
EMDN code
Q010301 Periodontal membranes
GMDN term
Collagen dental regeneration membrane
Device class
Class III EUDAMED
Class II GUDID
Regulation number
872.3930
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Width — 20 Millimeter
Length — 30 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.

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Properties

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