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Nordent Manufacturing, Inc.

by Nordent Manufacturing Inc. 166 variants

Ref Nordent Catalog Hygiene sectionModel OTC1104

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

CE MDR

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/MDR EUDAMED Number0840018681425Y Basic UDI-DI 00840018642195UDI-DIDate30 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840018642195 UDI-DI Date18 Jun 2020ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Bone file/rasp, manual, reusable
Device Name
Hard Wire Cutter
Model / Reference
OTC1104 EUDAMED
Nordent Catalog Hygiene section EUDAMED
RECSL85 GUDID
Primary DI / UDI-DI
00840018642195
Basic UDI-DI
0840018681425Y
FDA Product Code
EMK
EMDN Code
L150703 Orthodontic cutters, reusable
GMDN Term
Bone file/rasp, manual, reusable
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
OTC1104
Nordent Catalog Hygiene section
GUDID
RECSL85

Manufacturer details

EUDAMED SRN
US-MF-000048439
Authorised representative
Ukens Dental DE-AR-000022084

Other devices from Nordent Manufacturing Inc

See all devices from Nordent Manufacturing Inc →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Expiration Date: No