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Guide Surgery Metal Sleeve

by Dentium Co., Ltd. 2 variants

Ref FMS54

Guide Surgery Metal Sleeve (FMS54) is a Class I device made by Dentium Co., Ltd., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 880969136DENTIUM006QB), 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 Number880969136DENTIUM006QB Basic UDI-DI 08809740719423UDI-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  • Withdrawn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
Sleeve
Model / reference
FMS54
Primary DI / UDI-DI
08809740719423
Basic UDI-DI
880969136DENTIUM006QB
EMDN code
Q010599 Dental instruments, single-use - other
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 DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

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See all devices from Dentium Co., Ltd. →

Properties

Other properties (14, all answered No)