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Root ZX mini RCM-7

by J.morita Mfg.corp.

Ref RCM-7

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

CE MDD

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/MDD EUDAMED NumberB-04548213015641 Basic UDI-DI 04548213015641UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04548213015641 UDI-DI Date7 Apr 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Root ZX mini
Generic Name
Endodontic apex locator
Model / Reference
RCM-7
Description
Apex Locator, Changed from 4548213019434, which was discontinued (replaced). Internal code RCM-7-RAL.
Primary DI / UDI-DI
04548213015641
Basic UDI-DI
B-04548213015641
510(k) Number
FDA Product Code
LQY
EMDN Code
Z12119009 Apex locators
GMDN Term
Endodontic apex locator
Device Class
Class IIa EUDAMED
U GUDID
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
U

Related devices

Cleared under the same submission (K090925)

Other devices from J.morita Mfg.corp.

See all devices from J.morita Mfg.corp. →

Properties

  • Single Use
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Lot / Batch Number: No
  • Expiration Date: No