Wexler Surgical, Inc.

Certificate 25 0358 QR/NB

Issued

Valid until: Sep 14, 2030

Certificate 25 0358 QR/NB is a valid Quality management system issued to Wexler Surgical, Inc. and registered in EUDAMED. Valid until September 14, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 25 0358 QR/NB
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 102325 0358 QR/NB

Validity

Issued: Sep 15, 2025
Valid from: Sep 15, 2025
Valid until: Sep 14, 2030

Manufacturer

Manufacturer: Wexler Surgical, Inc.
Manufacturer SRN: US-MF-000041644
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 1023
Notified body country: Czechia

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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I8

8 scopes

Clamps, Forceps, Ligature Appliers, Passers, Pushers, Tyers, Needle Holders, Retracting Instruments, Surgical Cutting Instruments, Surgical Suction Instruments
Class I
Clamps
Class I
Forceps
Class I
Ligature Appliers, Passers, Pushers, Tyers
Class I
Needle Holders
Class I
Retracting Instruments
Class I
Surgical Cutting Instruments
Class I
Surgical Suction Instruments
Class I

Documents

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