Bausch & Lomb GmbH

Certificate HZ 2520883-1

Rev. Rev. 3Supplemented

Valid until: Apr 26, 2028

Overview

Certificate number: HZ 2520883-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2520883-1Rev. 3

Validity

Issued: Feb 19, 2026
Valid from: Feb 19, 2026
Valid until: Apr 26, 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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HZ 2520883-1Quality management systemSupplementedDec 17, 2024 → Apr 26, 2028

Scope coverage

Class IIa1Class I1

2 scopes

Q020101 - Ophthalmic Microknives Q021101 - Occular irrigation and aspiration cannulas, single use Q021102 - Ophthalmic Surgery Foreceps, Single-Use Q021104 - Ophthalmic Surgery Manipulators, Single-Use Q021106 - Ophthalmic Surgery Dilators, Single-Use Q021109 - Ophthalmic Surgery Spatulas, Single-Use Q021199 - Ophthalmic Surgery Instruments, Single-Use - Other Q0299 - Ophthalmic Devices - Other
Class IIa
Products of class I, reusable surgical instruments: L010405 - OPHTHALMOLOGY SCISSORS, REUSABLE L1701 - OPHTHALMOLOGY DILATORS AND RETRACTORS, REUSABLE L1702 - OPHTHALMOLOGY FORCEPS, REUSABLE L1703 - OPHTHALMOLOGY CURETTES, REUSABLE L170401 - CORNEAL TREPHINES, REUSABLE L1705 - OPHTHALMOLOGY PROBES, REUSABLE L1706 - OPHTHALMOLOGY SPATULAS, REUSABLE L1707 - OPHTHALMOLOGY SPOONS, REUSABLE L1711 - OPHTHALMOLOGY HOOKS, REUSABLE
Class I

Documents

LanguagesEN

Bausch & Lomb GmbH

Certificate HZ 2520883-1

Rev. Rev. 3Supplemented

Valid until: Apr 26, 2028

Overview

Certificate number: HZ 2520883-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2520883-1Rev. 3

Validity

Issued: Feb 19, 2026
Valid from: Feb 19, 2026
Valid until: Apr 26, 2028

Manufacturer

Manufacturer: Bausch & Lomb GmbH
Manufacturer SRN: DE-MF-000009142
Manufacturer country: Germany

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HZ 2520883-1Quality management systemSupplementedDec 17, 2024 → Apr 26, 2028

Scope coverage

Class IIa1Class I1

2 scopes

Q020101 - Ophthalmic Microknives Q021101 - Occular irrigation and aspiration cannulas, single use Q021102 - Ophthalmic Surgery Foreceps, Single-Use Q021104 - Ophthalmic Surgery Manipulators, Single-Use Q021106 - Ophthalmic Surgery Dilators, Single-Use Q021109 - Ophthalmic Surgery Spatulas, Single-Use Q021199 - Ophthalmic Surgery Instruments, Single-Use - Other Q0299 - Ophthalmic Devices - Other
Class IIa
Products of class I, reusable surgical instruments: L010405 - OPHTHALMOLOGY SCISSORS, REUSABLE L1701 - OPHTHALMOLOGY DILATORS AND RETRACTORS, REUSABLE L1702 - OPHTHALMOLOGY FORCEPS, REUSABLE L1703 - OPHTHALMOLOGY CURETTES, REUSABLE L170401 - CORNEAL TREPHINES, REUSABLE L1705 - OPHTHALMOLOGY PROBES, REUSABLE L1706 - OPHTHALMOLOGY SPATULAS, REUSABLE L1707 - OPHTHALMOLOGY SPOONS, REUSABLE L1711 - OPHTHALMOLOGY HOOKS, REUSABLE
Class I

Documents

LanguagesEN