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Ball Analog

by Dentium Co., Ltd.

Ref GBANL

Ball Analog (GBANL) is a Class I device made by Dentium Co., Ltd., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 880969136DENTIUM007QD), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880969136DENTIUM007QD Basic UDI-DI 08809740710413UDI-DIDate2 Nov 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  • Withdrawn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
Laboratory instruments
Model / reference
GBANL
Primary DI / UDI-DI
08809740710413
Basic UDI-DI
880969136DENTIUM007QD
EMDN code
Q010207 Dental impression devices for prosthetic dentistry
Device class
Class I
EU registration type
Standard device
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
KR-MF-000023279
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Dentium Co., Ltd.

See all devices from Dentium Co., Ltd. →

Properties

Other properties (14, all answered No)