Erbe Vision GmbH

Certificate D1192000031

Supplemented

Valid until: May 21, 2028

Certificate D1192000031 is a valid Quality management system issued to Erbe Vision GmbH and registered in EUDAMED. Valid until May 21, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: D1192000031
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0483D1192000031

Validity

Issued: Jun 11, 2026
Valid from: Jun 11, 2026
Valid until: May 21, 2028

Manufacturer

Manufacturer: Erbe Vision GmbH
Manufacturer SRN: DE-MF-000010268
Manufacturer country: Germany

Notified body

Notified body
Notified body SRN: 0483
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

Status changes

Supplemented

Supersedes

D1192000030SupplementedDec 18, 2025 → May 21, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa7

7 scopes

Laparoscope
Class IIa
Hysteroscope
Class IIa
Sleeves- Hysteroscopy system
Class IIa
Cystoscope
Class IIa
Cystoscopy and Urethroscopy Sheaths and working element
Class IIa
Urethrotomy instruments - Sleeves and guide tube
Class IIa
Lithiotripsy instruments - Sheath and telescopic bridge
Class IIa

Documents

LanguagesDE