Olympus Winter & Ibe GmbH

Certificate HZ 1845129-1

Rev. Rev. 10SupplementedExpired

Valid until: Apr 20, 2025

Overview

Certificate number: HZ 1845129-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 8
Certificate ID: 0197HZ 1845129-1Rev. 10

Validity

Issued: Feb 7, 2025
Valid from: Feb 7, 2025
Valid until: Apr 20, 2025

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: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 1845129-1Quality management systemSupplementedSep 20, 2024 → Apr 20, 2025

Scope coverage

Class IIb10Class IIa5Class I5

17 scopes

- K020301 - Radiofrequency Surgery Instruments, Single-Use
Class IIb
- Z120207 - Genitourinary Endoscopy Instruments
Class IIa
- U090299 - Urogenital Endoscopic Resection Instrumentary - Others
Class IIaClass I
- L1299 - Laparoscopic and Thoracoscopic Instruments, Reusable – Other
Class IIaClass I
- Z120210 - ENT Endoscopy Instruments
Class IIa
- L180502 - Endoscopic Electrosurgery Multifunctional Cannulas, Reusable Electrosurgery Multifunctional Cannulas, Reusable
Class IIb
- Z120109 - General and Multidisciplinary Surgery Instruments Electrosurgery Instruments
Class IIb
- Z120290 - Various Instruments for Endoscopy And Mini- Invasive Surgery
Class IIa
- Z120108 - Instruments For Ultrasonic Surgery
Class IIb
- L060403 - Endoscopic Urology Forceps, Reusable
Class IIbClass I
- L060401 - Endoscopic Urology Scissors, Reusable
Class I
- L060499 - Endoscopic Urology Instruments, Reusable - Other
Class I
- L180602 - Endoscopic Electrosurgery Electrodes, Reusable
Class IIb
- L1899 - Electrosurgery Instruments, Reusable – Other
Class IIb
- L180202 - Endoscopic Electrosurgery Scissors, Reusable
Class IIb
- L180302 - Endoscopic Electrosurgery Handpieces, Reusable
Class IIb
- L180402 - Endoscopic Electrosurgery Forceps, Reusable
Class IIb

Documents

LanguagesEN

Scope coverage

Class IIb10Class IIa5Class I5

17 scopes

- K020301 - Radiofrequency Surgery Instruments, Single-Use
Class IIb
- Z120207 - Genitourinary Endoscopy Instruments
Class IIa
- U090299 - Urogenital Endoscopic Resection Instrumentary - Others
Class IIaClass I
- L1299 - Laparoscopic and Thoracoscopic Instruments, Reusable – Other
Class IIaClass I
- Z120210 - ENT Endoscopy Instruments
Class IIa
- L180502 - Endoscopic Electrosurgery Multifunctional Cannulas, Reusable Electrosurgery Multifunctional Cannulas, Reusable
Class IIb
- Z120109 - General and Multidisciplinary Surgery Instruments Electrosurgery Instruments
Class IIb
- Z120290 - Various Instruments for Endoscopy And Mini- Invasive Surgery
Class IIa
- Z120108 - Instruments For Ultrasonic Surgery
Class IIb
- L060403 - Endoscopic Urology Forceps, Reusable
Class IIbClass I
- L060401 - Endoscopic Urology Scissors, Reusable
Class I
- L060499 - Endoscopic Urology Instruments, Reusable - Other
Class I
- L180602 - Endoscopic Electrosurgery Electrodes, Reusable
Class IIb
- L1899 - Electrosurgery Instruments, Reusable – Other
Class IIb
- L180202 - Endoscopic Electrosurgery Scissors, Reusable
Class IIb
- L180302 - Endoscopic Electrosurgery Handpieces, Reusable
Class IIb
- L180402 - Endoscopic Electrosurgery Forceps, Reusable
Class IIb

Certificate HZ 1845129-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 1845129-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer