ReGelTec Inc.

Certificate 28620211490

Rev. 00Issued

Valid until: Nov 28, 2027

Certificate 28620211490 is a valid Quality management system issued to ReGelTec Inc. and registered in EUDAMED. Valid until November 28, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620211490
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862021149000

Validity

Issued: May 5, 2025
Valid from: May 5, 2025
Valid until: Nov 28, 2027

Notified body

Notified body: Intertek Medical Notified Body AB
Notified body SRN: 2862
Notified body country: Sweden

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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

Sterile spine disc displacement system
Class III
Hydrafil Delivery System including Hydrafil Implant
Class III

Documents

LanguagesEN