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Absorbent Paper Points, 04-45 2438

by Meta Biomed, Inc.

Model 04-45

Absorbent Paper Points, 04-45 2438 is a device classified as Class IIa in the EU and Class I in the US made by Meta Biomed, Inc., registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI B-08806387824381) and listed in FDA GUDID since 24 Sep 2022 (UDI-DI 08806387824381), 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-08806387824381 Basic UDI-DI 08806387824381UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806387824381 UDI-DI Date24 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806387824381 registered 19 Jun 2026 Active
  • FDA GUDID UDI-DI 08806387824381 listed 24 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806387824381
  2. Registered EUDAMED B-08806387824381

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  • Withdrawn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
Absorbent Paper Points EUDAMED
Absorbent Paper Points, 04-45 GUDID
Generic name
Endodontic paper point
Device name
Sterile Absorbent Paper Points
Model / reference
04-45 EUDAMED
2438 GUDID
Primary DI / UDI-DI
08806387824381
Basic UDI-DI
B-08806387824381
FDA product code
EKN
EMDN code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN term
Endodontic paper point
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3830
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04-45
GUDID
2438
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08806387824381: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa 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: Endodontic paper point

Similar devices in this category

Other devices filed under PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY.

Other devices from Meta Biomed, Inc.

See all devices from Meta Biomed, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)