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Mani Dia-Burs - Ex-11SC

by Mani, Inc.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04546951610340 Basic UDI-DI 04546951610340UDI-DIDate13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04546951610340 UDI-DI Date10 Dec 2022ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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

Trade Name
Mani Dia-Burs - Ex-11SC EUDAMED
Mani Dia-Burs GUDID
Generic Name
Diamond dental bur, reusable
Model / Reference
EX-11SC
Primary DI / UDI-DI
04546951610340
Basic UDI-DI
B-04546951610340, 4546951000018ZS
Unit of Use DI
74546951610349
FDA Product Code
DZP
EMDN Code
L159007 Odontostomatology burs, reusable
GMDN Term
Diamond dental bur, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4535
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
JP-MF-000017860
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Mani, Inc.

See all devices from Mani, Inc. →

Properties

  • Reusable
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No