Check certificate HZ 2292034-1 in seconds
The Research Assistant checks certificate status, issuer and covered devices — and cites every record.
Free to try · every answer cites its records
Basic Information
- Number
- HZ 2292034-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- August 16, 2024
- Expiry Date
- August 15, 2029
- Revision
- Rev.0
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Certificate Lifecycle
Device Characteristics
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
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.
Quality Procedure Scope
Product of Class IIa: L159099 - ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER Q010599 - DENTAL INSTRUMENTS, SINGLE-USE - OTHER L159016 - DENTAL SURGERY INSTRUMENT KITS, REUSABLE
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.