Reach Surgical,Inc.

Certificate HZ 2064405-1

Rev. Rev.4Supplemented

Valid until: Nov 21, 2028

Certificate HZ 2064405-1 is a valid Quality management system issued to Reach Surgical,Inc. and registered in EUDAMED. Valid until November 21, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2064405-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0197HZ 2064405-1Rev.4

Validity

Issued: Mar 27, 2026
Valid from: Mar 27, 2026
Valid until: Nov 21, 2028

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: 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: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 2064405-1Quality management systemSupplementedMar 20, 2025 → Nov 21, 2028

Scope coverage

Class IIa1Class IIb1

2 scopes

H020301 - LINEAR STAPLERS FOR VIDEOSURGERY H020201 - LINEAR STAPLERS, OPEN SURGERY K010101 - TROCAR, SINGLE-USE
Class IIa
H020301 - STAPLERS FOR VIDEOSURGERY LINEAR STAPLERS FOR VIDEOSURGERY Z120108 - GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS INSTRUMENTS FOR ULTRASONIC SURGERY K020201 - DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE ULTRASONIC SURGERY INSTRUMENTS, SINGLE-USE Z120109 - GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS ELECTROSURGICAL INSTRUMENTS K020101 - MONO- AND BIPOLAR DEVICES, SINGLE-USE MONO- AND BIPOLAR SURGICAL INSTRUMENTS, SINGLE-USE
Class IIb

Documents

LanguagesEN