Meril Diagnostics Pvt. Ltd.

Certificate 2025-IVDR/TD-001/A

Rev. 01Amended

Valid until: Sep 9, 2028

Certificate 2025-IVDR/TD-001/A is a valid Technical documentation issued to Meril Diagnostics Pvt. Ltd. and registered in EUDAMED. Valid until September 9, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-IVDR/TD-001/A
Certificate type: Technical documentation
Certificate status: Amended
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 2
Certificate ID: 22652025-IVDR/TD-001/A01

Validity

Issued: Jun 30, 2026
Valid from: Jun 30, 2026
Valid until: Sep 9, 2028

Manufacturer

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
Manufacturer country: India

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

HIVFIND™ Oral Fluid HIV 1/2 Antibody Detection Self TestIVDR Class D
8905459HIVOSF9V

Linked SSCPs

SSCP CE-SSP/IM/CLD/023

Characteristics

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

History

Status changes

Amended

Supersedes

2025-IVDR/TD-001Technical documentationIssuedMar 20, 2025 → Sep 9, 2028

Scope coverage

IVDR Class D1

1 scope

HIVFIND™ Oral Fluid HIV 1/2 Antibody Detection Self Test
IVDR Class D
8905459HIVOSF9V

Documents

LanguagesEN