United Orthopedic Corporation

Certificate MDR 758452

Rev. R001Supplemented

Valid until: Aug 17, 2027

Certificate MDR 758452 is a valid Quality management system issued to United Orthopedic Corporation and registered in EUDAMED. Valid until August 17, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 758452
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 758452R001

Validity

Issued: Jun 11, 2026
Valid from: Jun 11, 2026
Valid until: Aug 17, 2027

Manufacturer

Manufacturer: United Orthopedic Corporation
Manufacturer SRN: TW-MF-000009523
Manufacturer country: Taiwan

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

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: Yes
SPP applicable

History

Status changes

Supplemented

Supersedes

MDR 758452SupplementedDec 4, 2025 → Aug 17, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III3Class IIb2Class I1

6 scopes

Custom-Made Joint Replacements
Class III
Femoral Heads
Class III
Hip Prosthesis - Accessories
Class IIb
Knee Prosthesis - Accessories
Class IIb
Reusable surgical instruments 'Orthopaedic Instruments'
Class I
U2 Total Knee System
Class III

Documents

LanguagesEN