LONGFIAN SCITECH CO.,LTD.

Certificate HZ 2018637-1

Rev. 0Issued

Valid until: Jul 5, 2031

Certificate HZ 2018637-1 is a valid Quality management system issued to LONGFIAN SCITECH CO.,LTD. and registered in EUDAMED. Valid until July 5, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2018637-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2018637-10

Validity

Issued: Jul 6, 2026
Valid from: Jul 6, 2026
Valid until: Jul 5, 2031

Manufacturer

Manufacturer: LONGFIAN SCITECH CO.,LTD.
Manufacturer SRN: CN-MF-000028163
Manufacturer country: China

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

Z121590 - PNEUMONOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS
Class IIb

Documents

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