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Certificate 51523-60-02-00 — Artivion, Inc.

MD Atlas
Documents

Artivion, Inc.

Certificate 51523-60-02-00

Supplemented

Valid until: Dec 18, 2027

Certificate 51523-60-02-00 is a valid Quality management system issued to Artivion, Inc. and registered in EUDAMED. Valid until December 18, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 51523-60-02-00
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 012451523-60-02-00

Validity

Issued: Sep 9, 2025
Valid from: Sep 9, 2025
Valid until: Dec 18, 2027

Notified body

Notified body
Notified body SRN: 0124
Notified body country: Germany

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: Yes
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

51523-60-01Quality management systemIssuedFeb 17, 2023 → Dec 18, 2027

Scope coverage

Class III3

3 scopes

DEVICE
Class III
BioGlue Surgical Adhesive Accessories
Class III
DEVICE
Class III

Documents

LanguagesEN

No

Conditions applicable

No

MOS outside EUDAMED

No

QMS/MOS type

Basic UDI-DI data only

DEKRA Certification GmbH

Manufacturer

Manufacturer: Artivion, Inc.
Manufacturer SRN: US-MF-000015763
Manufacturer country: United States

Covered devices

BioGlue Surgical AdhesiveClass III
87723400BG35007W
PhotoFix Decellularized Bovine PericardiumClass III
87723400PFP3L