Shanwei Perfect Medical Instruments Co.,Ltd.

Certificate HZ 2495355-1

Rev. Rev.0Issued

Valid until: Jan 15, 2031

Certificate HZ 2495355-1 is a valid Quality management system issued to Shanwei Perfect Medical Instruments Co.,Ltd. and registered in EUDAMED. Valid until January 15, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2495355-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2495355-1Rev.0

Validity

Issued: Jan 16, 2026
Valid from: Jan 16, 2026
Valid until: Jan 15, 2031

Manufacturer

Manufacturer
Manufacturer SRN: CN-MF-000033003
Manufacturer country: China

Notified body

Notified body
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

Q010507 - ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE Z121101 - INSTRUMENTS FOR DENTAL TREATMENT UNITS
Class IIa

Documents

LanguagesEN