EDDA Technology, Inc.

Certificate HZ 2213011-1

Rev. 1Supplemented

Valid until: Dec 16, 2030

Certificate HZ 2213011-1 is a valid Quality management system issued to EDDA Technology, Inc. and registered in EUDAMED. Valid until December 16, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2213011-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2213011-11

Validity

Issued: Jun 11, 2026
Valid from: Jun 11, 2026
Valid until: Dec 16, 2030

Manufacturer

Manufacturer: EDDA Technology, Inc.
Manufacturer SRN: US-MF-000050953
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 2213011-1Quality management systemIssuedDec 17, 2025 → Dec 16, 2030

Scope coverage

Class IIa1

1 scope

Products of Class IIa: Z11030592 Radiology Instruments – Medical Device Software
Class IIa

Documents

LanguagesEN