Skip to content

Adseal

by Meta Biomed Co., Ltd.

Model ADSEAL

Adseal is a device classified as Class IIa in the EU and Class II in the US made by Meta Biomed Co., Ltd., registered in EUDAMED on 28 Apr 2026 (Basic UDI-DI B-08806387892069) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 08806387892069), 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-08806387892069 Basic UDI-DI 08806387892069UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806387892069 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806387892069 registered 28 Apr 2026 Active
  • FDA GUDID UDI-DI 08806387892069 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806387892069
  2. Registered EUDAMED B-08806387892069

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  • Withdrawn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
Dental epoxy resin
Model / reference
ADSEAL EUDAMED
9206 GUDID
Primary DI / UDI-DI
08806387892069
Basic UDI-DI
B-08806387892069
FDA product code
KIF
EMDN code
Q01010202 Root canal filling dental cements
GMDN term
Dental epoxy resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3820
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ADSEAL
GUDID
9206
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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

Manufacturer details

EUDAMED SRN
KR-MF-000009681
Authorised representative
Meta Biomed Europe GmbH DE-AR-000004953

Related devices

Category: Calcium hydroxide dental cement

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL CEMENTS.

Other devices from Meta Biomed Co., Ltd.

See all devices from Meta Biomed Co., Ltd. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)