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MANI SEC O-FILES, K - 21mm #55

by Mani, Inc.

Model HAND FILES

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

CE MDR 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number4546951000001Z9 Basic UDI-DI 04546951505516UDI-DIDate13 Nov 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number4546951000001Z9 Basic UDI-DI 04546951505516UDI-DIDate13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04546951505516 UDI-DI Date8 Oct 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  • Withdrawn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, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MANI SEC O-FILES,K - 21mm #55 EUDAMED
Mani Sec O-Files,k GUDID
Generic Name
Manual endodontic file/rasp, reusable
Model / Reference
HAND FILES EUDAMED
21mm #55 GUDID
Primary DI / UDI-DI
04546951505516
Basic UDI-DI
4546951000001Z9, B-04546951505516
Unit of Use DI
74546951505515
FDA Product Code
EKS
EMDN Code
L159004 Endodontic rasps and files, reusable
GMDN Term
Manual endodontic file/rasp, reusable
Device Class
Class I
Regulation Number
872.4565
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
Model / ReferenceEUDAMED
HAND FILES
GUDID
21mm #55

Manufacturer details

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

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from Mani, Inc.

See all devices from Mani, Inc. →

Properties

  • Reusable
  • CMR Substance YesEUDAMEDNoEUDAMED
  • 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