certifications
Certifications
Shuer Medical operates under a certified quality management system and holds CE marking under EU MDR for our core product lines. Full documentation is available for download below.
Quality management system
ISO 13485:2016 (GB/T 42061-2022)
Medical Devices Quality Management System — confirms our factory operates a certified process for the design, production and control of medical devices, covering medical absorbent pads, medical protective masks, medical graphene isolation gowns and surgical masks.
| Certificate number | HG25MD0033R0S |
| Issued | Nov 15, 2025 |
| Expires | Nov 14, 2028 |
| Issuing body | Crown Certification Testing Co., Ltd. |
CE marking (EU MDR 2017/745)
Independently tested and certified by RENOWS Certification Testing Co., Ltd. against Regulation (EU) 2017/745 on Medical Devices, Class I Non-sterile.
Medical mask
N95, KN95, flat mask, 3D mask, FFP2 cup shape mask, surgical mask, protective mask
| Certificate no. | UNICO20260126SE01 |
| Valid | Jan 26, 2026 – Jan 26, 2031 |
Medical absorbent pad
Fluid absorption pad, unfluid absorption pad
| Certificate no. | UNICO20260126SE02 |
| Valid | Jan 26, 2026 – Jan 26, 2031 |
Medical care pad
S / M / L / XL / XXL / XXXL
| Certificate no. | UNICO20260126SE04 |
| Valid | Jan 26, 2026 – Jan 26, 2031 |
Declarations of conformity
Manufacturer-issued declarations under EU MDR 2017/745, covering our full PP, graphene and PLA product range. All reference the same underlying test reports and standards as our CE certificates.
| Device | Model(s) | Document no. |
|---|---|---|
| Medical mask | N95 / KN95 / flat / 3D / FFP2 cup shape / surgical / protective | S-YQ-MD-2601070098/01 |
| Medical absorbent pad | Fluid absorption pad, unfluid absorption pad | S-YQ-MD-2601070098/02 |
| Medical wipes | N/A | S-YQ-MD-2601070098/03 |
| Medical care pad | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/04 |
| Medical PLA isolation gown | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/05 |
| Medical PLA protective suit | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/06 |
| Medical PLA underpad | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/07 |
| PLA care pad | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/08 |
| PLA shoecover | S / M / L / XL | S-YQ-MD-2601070098/09 |
| PLA protective cap | S / M / L / XL | S-YQ-MD-2601070098/10 |
| Medical graphene isolation gown | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/11 |
| Medical graphene protective suit | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/12 |
| Medical graphene under pad | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/13 |
| Graphene shoe cover | S / M / L / XL | S-YQ-MD-2601070098/14 |
| Graphene protective cap | S / M / L / XL | S-YQ-MD-2601070098/15 |
| Graphene diaper | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/16 |
| Graphene care pad | S / M / L / XL / XXL / XXXL | S-YQ-MD-2601070098/17 |
All declarations issued January 7, 2026.
Download full document (17 declarations)Additional certifications (including ISO 9001 and NIOSH) are in progress and will be published here once documentation is finalized. For certificate verification or additional documentation, please contact our team.