STORZ MEDICAL AG

Certificate HZ 1620952-1

Rev. Rev. 2Supplemented

Valid until: Jun 14, 2028

Certificate HZ 1620952-1 is a valid Quality management system issued to STORZ MEDICAL AG and registered in EUDAMED. Valid until June 14, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1620952-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 1620952-1Rev. 2

Validity

Issued: Mar 17, 2026
Valid from: Mar 17, 2026
Valid until: Jun 14, 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: No
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 1620952-1Quality management systemSupplementedFeb 20, 2025 → Jun 14, 2028

Scope coverage

Class IIb1Class IIa1

2 scopes

Z121601 - EXTRACORPOREAL LITHOTRIPSY INSTRUMENTS Z12160101 - EXTRACORPOREAL LITHOTRIPTERS Extracorporeal devices for shock-wave therapy (ESWL, ESWT) Z120402 - GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS Z120622 - MUSCLE STIMULATORS Z121011 - INSTRUMENTS FOR PERIPHERAL OR CENTRAL NEUROLOGIC STIMULATION AND EVALUATION Z121390 - VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS Z121690 - VARIOUS INSTRUMENTS FOR UROLOGY
Class IIb
Z121390: VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS Z120622: MUSCLE STIMULATORS Z121011: INSTRUMENTS FOR PERIPHERAL OR CENTRAL NEUROLOGIC STIMULATION AND EVALUATION Z121690: VARIOUS INSTRUMENTS FOR UROLOGY
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIb1Class IIa1

2 scopes

Z121601 - EXTRACORPOREAL LITHOTRIPSY INSTRUMENTS Z12160101 - EXTRACORPOREAL LITHOTRIPTERS Extracorporeal devices for shock-wave therapy (ESWL, ESWT) Z120402 - GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS Z120622 - MUSCLE STIMULATORS Z121011 - INSTRUMENTS FOR PERIPHERAL OR CENTRAL NEUROLOGIC STIMULATION AND EVALUATION Z121390 - VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS Z121690 - VARIOUS INSTRUMENTS FOR UROLOGY
Class IIb
Z121390: VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS Z120622: MUSCLE STIMULATORS Z121011: INSTRUMENTS FOR PERIPHERAL OR CENTRAL NEUROLOGIC STIMULATION AND EVALUATION Z121690: VARIOUS INSTRUMENTS FOR UROLOGY
Class IIa

Certificate HZ 1620952-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 1620952-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer