Quality

The production in our factory is under the Quality Control system ISO13485.

 

Standard: ISO13485 Number: Q6 051736 0013 Rev.00 Issue Date: 2019-05-06 Expiry Date: 2021-06-30 Scope/Range: Issued By: TUV SUD Product Service GmbH

Standard: EC CERTIFICATE Number: G2S 051736 0015 Rev.00 Issue Date: 2019-05-06 Expiry Date: 2023-11-27 Scope/Range: Issued By: TUV SUD Product Service GmbH

Standard: EC CERTIFICATE Number: G2 051736 0014 Rev.00 Issue Date: 2019-05-06 Expiry Date: 2023-11-27 Scope/Range: Issued By: TUV SUD Product Service GmbH

Standard: Meidcal Device Production Lincense Number: 鄂食药监械生产许可20200928号 Issue Date: 2020-06-29 Expiry Date: 2021-06-28 Scope/Range: Issued By: Chinese Medical Products Administration

Standard: Meidcal Face Mask Lincense Number: 鄂械注准20202142986 Issue Date: 2020-06-01 Expiry Date: 2021-05-31 Scope/Range: Issued By: Hubei Medical Products Administration

Standard: TYPE II OR TYPE IIR, BFE Number: 1206286-S01 Issue Date: 2019-07-25 Scope/Range: Medical/Surgical Face masks Issued By: Nelson Labs

Standard: TYPE II OR TYPE IIR, Microbial Cleanliness Number: 1206285-S01.2 Issue Date: 2019-08-12 Scope/Range: Surgical/Medical Face Mask Issued By: Nelson Labs

Standard: TYPE IIR Synthetic Blood Penetration Number: 1208613-S01 Issue Date: 2019-07-31 Scope/Range: Surgical/Medical Face Mask Issued By: Nelson Labs

Standard: EN13795 Number: SL52035285097201TX Issue Date: 2020-09-04 Scope/Range: Surgical Gowns, Isolation Gowns Issued By: SGS

Standard: AAMI Number: SL52035273874701TX Issue Date: 2020-08-03 Scope/Range: GOWNS Issued By: SGS

Standard: TYPE4/5/6 Number: 522676/1 Issue Date: 2017-07-18 Expiry Date: 2022-07-18 Scope/Range: COVERALL Issued By: BTTG

Standard: Declaration Of Conformity - PPE Regulation 2016-425-MC Number: Scope/Range: Issued By:

Standard: Declaration Of Conformity - PPE Regulation 2016-425-SMS Number: Scope/Range: Issued By: