LIMACORPORATE S.p.A.

Certificate 018-00-08-MDR

Rev. 8Supplemented

Valid until: May 3, 2028

Certificate 018-00-08-MDR is a valid Quality management system issued to LIMACORPORATE S.p.A. and registered in EUDAMED. Valid until May 3, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 018-00-08-MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0426018-00-08-MDR8

Validity

Issued: Oct 14, 2025
Valid from: Oct 14, 2025
Valid until: May 3, 2028

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

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: 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: Class IIb only

History

Status changes

Supplemented

Supersedes

018-00-07-MDRQuality management systemSupplementedSep 29, 2025 → May 3, 2028

Scope coverage

Class III11Class IIb1

12 scopes

Non-active osteo- and orthopaedic implants
Class III
Shoulder Prosthesis (PRIMA Humeral System)
Class III
Shoulder Prosthesis (SMR Stemless)
Class III
Shoulder Prosthesis (SMR Shoulder System)
Class III
Elbow Prosthesis (DISCOVERY Elbow System)
Class III
Shoulder Prosthesis (PRIMA Glenoid System)
Class III
Elbow Prosthesis: TEMA Elbow System
Class III
Knee Prosthesis: (MULTIGEN Plus)
Class III
Knee Prosthesis: Physica TT Tibial Plate, Physica KR Liner, Physica LMC Liner, Physica Patellar Prosthesis and Physica Porous Femoral Components
Class III
Knee Prosthesis: AMF (Anatomical Metaphyseal Fixation) TT Cones
Class IIb
Knee Prosthesis: Physica ZUK Unicompartmental Knee System Articular Surface (LimaVit)
Class III
Knee Prosthesis: Physica PS PRO
Class III

Documents

LanguagesENIT

Scope coverage

Class III11Class IIb1

12 scopes

Non-active osteo- and orthopaedic implants
Class III
Shoulder Prosthesis (PRIMA Humeral System)
Class III
Shoulder Prosthesis (SMR Stemless)
Class III
Shoulder Prosthesis (SMR Shoulder System)
Class III
Elbow Prosthesis (DISCOVERY Elbow System)
Class III
Shoulder Prosthesis (PRIMA Glenoid System)
Class III
Elbow Prosthesis: TEMA Elbow System
Class III
Knee Prosthesis: (MULTIGEN Plus)
Class III
Knee Prosthesis: Physica TT Tibial Plate, Physica KR Liner, Physica LMC Liner, Physica Patellar Prosthesis and Physica Porous Femoral Components
Class III
Knee Prosthesis: AMF (Anatomical Metaphyseal Fixation) TT Cones
Class IIb
Knee Prosthesis: Physica ZUK Unicompartmental Knee System Articular Surface (LimaVit)
Class III
Knee Prosthesis: Physica PS PRO
Class III

Certificate 018-00-08-MDR

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate 018-00-08-MDR

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer