OSSTEM IMPLANT Co., Ltd.

Certificate HZ 2292034-1

Rev. Rev.1Supplemented

Valid until: Aug 15, 2029

Certificate HZ 2292034-1 is a valid Quality management system issued to OSSTEM IMPLANT Co., Ltd. and registered in EUDAMED. Valid until August 15, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2292034-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2292034-1Rev.1

Validity

Issued: Sep 2, 2025
Valid from: Sep 2, 2025
Valid until: Aug 15, 2029

Manufacturer

Manufacturer
Manufacturer SRN: KR-MF-000020006
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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

History

Status changes

Supplemented

Supersedes

HZ 2292034-1Quality management systemIssuedAug 16, 2024 → Aug 15, 2029

Scope coverage

Class I1Class IIa1Class IIb1

3 scopes

Product of Class I, reusable surgical instruments: L159099 - ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER L159016 - DENTAL SURGERY INSTRUMENT KITS, REUSABLE The scope of certification is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
Class I
Product of Class IIa: L159099 - ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER Q010599 - DENTAL INSTRUMENTS, SINGLE-USE - OTHER L159016 - DENTAL SURGERY INSTRUMENT KITS, REUSABLE
Class IIa
Product of Class IIb implantable: P010201 - ODONTOLOGICAL PROSTHESES DENTAL IMPLANTS AND ACCESSORIES
Class IIb

Documents

LanguagesEN