Sandstone Medical(Suzhou) Inc.

Certificate G10 103844 0005

Rev. Rev. 00Issued

Valid until: Sep 11, 2029

Certificate G10 103844 0005 is a valid Quality management system issued to Sandstone Medical(Suzhou) Inc. and registered in EUDAMED. Valid until September 11, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 103844 0005
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 103844 0005Rev. 00

Validity

Issued: Sep 12, 2024
Valid from: Sep 12, 2024
Valid until: Sep 11, 2029

Manufacturer

Manufacturer: Sandstone Medical(Suzhou) Inc.
Manufacturer SRN: CN-MF-000011105
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

A0101010201 - HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS
Class IIa
A0101010202 - HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS
Class IIa

Documents

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