Blog Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Blog Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

MD Atlas
Documents

Kora Healthcare

Certificate GB25/00000076

Rev. 2Issued

Valid until: Apr 10, 2030

Overview

Certificate number: GB25/00000076
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639GB25/000000762

Validity

Issued: Jul 11, 2025
Valid from: Jul 11, 2025
Valid until: Apr 10, 2030

Manufacturer

Manufacturer: Kora Healthcare
Manufacturer SRN: IE-MF-000005159
Manufacturer country: Ireland

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
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: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb3

3 scopes

MDN1213, MDS1008 EMDN: U0803
Class IIb
Non-sterile, single use lactate vaginal gel for the treatment and prevention of bacterial vaginosis
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN