Shenzhen Poweray Biotechnology Co., Ltd.

We dedicate to develop reagents&instrument in POCT erea everyone can afford

Manufacturer from China
Active Member
4 Years
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Shenzhen Poweray Biotechnology Co., Ltd.
City:shenzhen
Country/Region:china
Contact Person:MsCarina
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Quality Control

We passed ISO13485 system certificate, and own CE certification for many products.
In terms of quality control, it includs multiple aspects, such as:
1. Regular maintainance of production equipment, as well as good records
2. Annual verification of key equipment
3. The raw material inspection records are classified and archived according to category, semi-finished and finished product inspection records are archived according to product items and batches, and the production records are archived accordingly
4. Purchase: Review and evaluate suppliers, conduct on-site audits when necessary, and sign a quality agreement with the suppliers after passing the audit to clarify the quality responsibilities of both parties
5. Sales: establish product sales records for traceability
6. Carry out management review annually.

Certifications
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: ISO
Number: 30418Q00615ROS
Issue Date: 2020-07-23
Expiry Date: 2023-07-22
Scope/Range: Specific protein analyzer and kit(for export only),Hha1c analyzer and kit(for export only),disposable virus sampling tube,nuclei
Issued By: CNCA
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: CE
Number: ECREP20211122.3
Issue Date: 2021-11-22
Expiry Date: 2024-12-04
Scope/Range: Nucleic Acid Extraction Reagent(magnetic bead method),Flu A & Flu B & COVID-19 Ag Rapid Test,COVID-19 RT - PCR Detection Kit,COV
Issued By: CMC
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: CE
Number: No.PS-DoC-01,A/0
Issue Date: 2020-08-26
Expiry Date: 2022-08-26
Scope/Range: Covid-19 RT-PCR Detection Kit
Issued By: CMC Medical Devices&Drugs S.L.
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: CE
Number: N.A.
Issue Date: 2010-08-14
Expiry Date: 2017-07-14
Scope/Range: Disposable Viurs Sampling Tube
Issued By: EU
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: ISO
Number: 30418Q00615ROS
Issue Date: 2020-07-23
Expiry Date: 2023-07-22
Scope/Range: Specific protein analyzer and kit(for export only),Hha1c analyzer and kit(for export only),disposable virus sampling tube,nuclei
Issued By: CNCA
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: CE
Number: ECREP20211122.3
Issue Date: 2021-11-22
Expiry Date: 2024-12-04
Scope/Range: Nucleic Acid Extraction Reagent(magnetic bead method),Flu A & Flu B & COVID-19 Ag Rapid Test,COVID-19 RT - PCR Detection Kit,COV
Issued By: CMC
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: CE
Number: No.PS-DoC-01,A/0
Issue Date: 2020-08-26
Expiry Date: 2022-08-26
Scope/Range: Covid-19 RT-PCR Detection Kit
Issued By: CMC Medical Devices&Drugs S.L.
Shenzhen Poweray Biotechnology Co., Ltd. Certifications
Standard: CE
Number: N.A.
Issue Date: 2010-08-14
Expiry Date: 2017-07-14
Scope/Range: Disposable Viurs Sampling Tube
Issued By: EU
Company Profile
Shenzhen Poweray Biotechnology Co., Ltd.
Contact Person: MsCarina