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Algasiv

by Combe Incorporated 16 variants

Part of a family of 16 devices: see the family page

Ref 00128-64

Algasiv (00128-64) is a Class I device made by Combe Incorporated, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 011509SeaBondPV), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number011509SeaBondPV Basic UDI-DI 10011509001280UDI-DIDate20 Aug 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Algasiv Denture Adhesive
Model / reference
00128-64
Primary DI / UDI-DI
10011509001280
Basic UDI-DI
011509SeaBondPV
EMDN code
Q010299 Prosthetic dentistry devices - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000024551
Authorised representative
COMBE EUROPA S.L ES-AR-000023377

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - OTHER.

Other devices from Combe Incorporated

See all devices from Combe Incorporated →

Properties

Other properties (14, all answered No)