GB/T 42061-2022
ISO 13485:2016 Medical Device Quality Management System Certificate
Quality & Compliance Auditable Standards
Verified Quality Systems
& Auditable Evidence
Documented quality scope and verified certification records for professional aesthetic medical B2B procurement.
Certified Standards
Quality Management System Certificates
Published with verified registration numbers, defined manufacturing scope and validity dates.
GB/T 19001-2016
ISO 9001:2015 Quality Management System Certificate
Air Transport Classification
Identification and Classification Report for Air Transport of Goods — Hyaluronic Acid Gel
Scope boundary
What the certificates do — and do not — cover
A quality management system certificate states a specific manufacturing scope. It is not a product registration or a market authorisation, and it does not extend automatically to every product line.
Within the stated scope
- HA dermal fillers (cross-linked hyaluronic acid dermal filler gel)
- Skin boosters built on the same HA gel scope
- Body HA fillers in bottled formats
- Orthopedic HA (medical sodium hyaluronate gel)
Separate categories — not covered
- Biostimulators (CaHA, PLLA)
- Exosome solutions
- PN and PDRN
- Mesotherapy cocktail formats
Documentation availability for these categories is confirmed per product and destination market. Request it before you commit to a launch.
QMS & Laboratory Control
Sterile Processing & Traceability
Product manufacturing and aseptic filling follow documented batch identification and in-process testing. Finished lot records and technical specification sheets are matched directly to each order.
- Lot Traceability: Batch numbers printed on primary ampoules and secondary retail boxes.
- Air Freight Safety: Identification and classification reports prepared for hyaluronic acid gel shipments.
- Document Packages: Batch Certificate of Analysis (CoA) and Technical Data Sheets (TDS) provided per order.
Document access
Batch and quality documentation is available to professional customers on request. Use the form below and tell us which products, markets and purpose you need it for; we will respond with what we are able to provide.
- Certificate of Analysis (COA) — issued per batch. Available against a specific batch number once the batch is allocated to your order.
- Safety Data Sheet (SDS / MSDS) — available for each product for regulatory and handling purposes.
- Quality management system certificates — the ISO 13485 and ISO 9001 certificates on this page, with scope and validity stated.
- Transport classification — the air transport classification report supporting shipment of the relevant products.
- Market registration files — where a registration or authorisation exists for a product and market, supporting documents can be discussed for the purposes of your own import or registration process.
Some documents are released only in preview or against a confirmed order, because they are batch-specific or are issued for a named consignee. We do not provide documents for products or markets where we cannot support the claim being made. If a document you need is not available, we will tell you rather than substitute a document for the wrong product.
Request for quotation
Request Quality Documents & Specification Sheets
Direct response with technical specifications, tiered quotation and country-specific documentation status.