Graham Medical Technologies, LLC

Certificate US25/00000280

Rev. 2Issued

Valid until: Jul 8, 2030

Certificate US25/00000280 is a valid Quality management system issued to Graham Medical Technologies, LLC and registered in EUDAMED. Valid until July 8, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: US25/00000280
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639US25/000002802

Validity

Issued: Jul 8, 2025
Valid from: Jul 30, 2025
Valid until: Jul 8, 2030

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: Yes
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 I2Class IIb2

4 scopes

MDN1208, MDS1006
Class I
MDN1102, MDS1005 EMDN: P090605
Class IIb
HyProCure Sinus Tarsi Instrument Set
Class I
Sterile HyProCure Sinus Tarsi Implant System
Class IIb

Documents

LanguagesEN