Skip to content

Tip Cover L

by Nakanishi Inc.

Ref Z217850Model MDA0000127

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number45602249800001277A Basic UDI-DI 04560264502147UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560264502147 UDI-DI Date21 Jan 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Ultrasonic dental scaling/debridement system
Model / Reference
MDA0000127 EUDAMED
Z217850 EUDAMED
Tip Cover L GUDID
Primary DI / UDI-DI
04560264502147
Basic UDI-DI
45602249800001277A
Direct Marketing DI
04589551387168
510(k) Number
FDA Product Code
ELC
EMDN Code
Z12110180 Instruments for dental treatment units - hardware accessories
GMDN Term
Ultrasonic dental scaling/debridement system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.4850
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MDA0000127
Z217850
GUDID
Tip Cover L
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K113530)

Show all (12)

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No