ReGelTec Inc.

Certificate 28620211491

Issued

Valid until: Nov 28, 2027

Certificate 28620211491 is a valid Technical documentation issued to ReGelTec Inc. and registered in EUDAMED. Valid until November 28, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620211491
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 286228620211491

Validity

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

Manufacturer

Manufacturer: ReGelTec Inc.
Manufacturer SRN: US-MF-000025182
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2862
Notified body country: Sweden

Covered devices

HYDRAFIL Procedure KitClass III
0195893BM2022FG

Linked SSCPs

SSCP CE-2022-SSCP

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III1

1 scope

HYDRAFIL Procedure Kit
Class III
0195893BM2022FG

Documents

LanguagesEN