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Million

by Yamahachi Dental Mfg., Co. 810 variants

Ref 20PCS,32,UR5,B2

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-PUMILXX32R5XB2 Basic UDI-DI PUMILXX32R5XB2UDI-DIDate5 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
20PCS, 32, UR5, B2
Primary DI / UDI-DI
PUMILXX32R5XB2
Basic UDI-DI
B-PUMILXX32R5XB2
EMDN code
Q01020601 Mobile dental prostheses
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000024849
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Partial denture

Similar devices

Also classified as Partial denture.

Other devices from Yamahachi Dental Mfg., Co.

See all devices from Yamahachi Dental Mfg., Co. →

Properties

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No