Alcon Laboratories, Inc.

Certificate G12 020895 0421

Rev. Rev. 00Issued

Valid until: Jun 11, 2031

Certificate G12 020895 0421 is a valid Quality management system issued to Alcon Laboratories, Inc. and registered in EUDAMED. Valid until June 11, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: G12 020895 0421
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G12 020895 0421Rev. 00

Validity

Issued: Jun 12, 2026
Valid from: Jun 12, 2026
Valid until: Jun 11, 2031

Manufacturer

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0123
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

P030102 - IOLs, APHAKIC The PMMA, biconvex, monofocal, single-piece posterior chamber intraocular lens is intended to be placed in the posterior chamber of the eye using a scleral fixation technique, replacing the human crystalline lens.
Class IIb

Documents

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