J. MORITA MFG. CORP.

Certificate HZ 2093717-1

Rev. 1Supplemented

Valid until: Feb 27, 2029

Certificate HZ 2093717-1 is a valid Quality management system issued to J. MORITA MFG. CORP. and registered in EUDAMED. Valid until February 27, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2093717-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2093717-11

Validity

Issued: Jul 23, 2025
Valid from: Jul 23, 2025
Valid until: Feb 27, 2029

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 2093717-1Quality management systemIssuedFeb 29, 2024 → Feb 27, 2029

Scope coverage

Class IIb1Class IIa1

2 scopes

Z110303 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS INSTRUMENTS FOR ORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY
Class IIb
Z121101 - INSTRUMENTS FOR DENTAL TREATMENT UNITS Z121190 – VARIOUS DENTAL STOMATOLOGY INSTRUMENTS
Class IIa

Documents

LanguagesEN