SONOSCAPE MEDICAL CORP.

Certificate HZ 2027206-1

Rev. Rev.6Supplemented

Valid until: Jul 29, 2027

Certificate HZ 2027206-1 is a valid Quality management system issued to SONOSCAPE MEDICAL CORP. and registered in EUDAMED. Valid until July 29, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2027206-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2027206-1Rev.6

Validity

Issued: Feb 12, 2026
Valid from: Feb 12, 2026
Valid until: Jul 29, 2027

Manufacturer

Manufacturer: SONOSCAPE MEDICAL CORP.
Manufacturer SRN: CN-MF-000009623
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: 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 2027206-1Quality management systemSupplementedSep 26, 2025 → Jul 29, 2027

Scope coverage

Class I1Class IIa1Class IIb1

3 scopes

Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120206 - LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120208 - PULMONARY ENDOSCOPIC INSTRUMENTS
Class I
Z110401 - ULTRASOUND SCANNERS Z110402 - ULTRASOUND PROBES Z120204 - INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120206 - LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY Z120208 - PULMONARY ENDOSCOPIC INSTRUMENTS Z120207 - GENITOURINARY ENDOSCOPY INSTRUMENTS Z120210 - ENT ENDOSCOPY INSTRUMENTS
Class IIa
Z120290 - ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY INSTRUMENTS VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINIINVASIVE SURGERY
Class IIb

Documents

LanguagesEN