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 |
| Expiry Date: | |
| 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 |
| Expiry Date: | |
| Scope/Range: | Surgical/Medical Face Mask |
| Issued By: | Nelson Labs |
| Standard: | TYPE IIR Synthetic Blood Penetration |
|---|---|
| Number: | 1208613-S01 |
| Issue Date: | 2019-07-31 |
| Expiry Date: | |
| Scope/Range: | Surgical/Medical Face Mask |
| Issued By: | Nelson Labs |
| Standard: | EN13795 |
|---|---|
| Number: | SL52035285097201TX |
| Issue Date: | 2020-09-04 |
| Expiry Date: | |
| Scope/Range: | Surgical Gowns, Isolation Gowns |
| Issued By: | SGS |
| Standard: | AAMI |
|---|---|
| Number: | SL52035273874701TX |
| Issue Date: | 2020-08-03 |
| Expiry Date: | |
| 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: | |
| Issue Date: | |
| Expiry Date: | |
| Scope/Range: | |
| Issued By: |
| Standard: | Declaration Of Conformity - PPE Regulation 2016-425-SMS |
|---|---|
| Number: | |
| Issue Date: | |
| Expiry Date: | |
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