MDR MDR QMS Supplemented

HZ 2520883-1

Manufacturer: Bausch & Lomb GmbH
Basic UDI-DIs
0
Scopes
2
Preceding Certs
1
Risk Classes
2
Characteristics
1
Revision
Rev. 2
687
Valid for 687 days
Expiry: April 26, 2028

Basic Information

Number
HZ 2520883-1
Type
MDR QMS
Legislation
MDR
Issue Date
December 17, 2024
Expiry Date
April 26, 2028
Revision
Rev. 2
Manufacturer
Bausch & Lomb GmbH

Certificate Lifecycle

December 17, 2024 April 26, 2028

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class I Reusable Surgical Instrument

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

Quality Procedure Scope

Device Group Class IIa

Q021101 - Occular irrigation and aspiration cannulas, single use

Preceding Certificates

HZ 2520883-1 Issued
Issued: August 24, 2023 Expires: April 26, 2028

Basic UDI-DIs

This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.