Shenzhen Dymind Biotechnology Co., Ltd.

Certificate HX 2183501-1

Rev. 0Issued

Valid until: Jun 13, 2029

Certificate HX 2183501-1 is a valid Quality management system issued to Shenzhen Dymind Biotechnology Co., Ltd. and registered in EUDAMED. Valid until June 13, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 2183501-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197HX 2183501-10

Validity

Issued: Jun 14, 2024
Valid from: Jun 14, 2024
Valid until: Jun 13, 2029

Manufacturer

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
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: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B1IVDR Class C1

2 scopes

HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W02020101 - AUTOMATED 5 PART DIFFERENTIAL HEMATOLOGY ANALYSERS W02020102 - LIMITED PANEL CELL COUNTING ANALYSERS HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030105 - HAEMATOLOGY CONTROLS AND CALIBRATORS
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 506: Other devices intended to be used to determine markers of infections/immune status W01021109 - C-REACTIVE PROTEIN W01021199 - RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Class C

Documents

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