Quality & Certifications

Every claim on this site has a certificate number

Procurement teams verify before they trust. Below: our complete registration list with numbers and validity dates — checkable on the NMPA public database — plus our three-stage QC process.

Quality Control

Three gates before anything ships

IQC — Incoming

Raw materials and packaging quarantined until identity, purity and microbial checks pass. Suppliers audited annually. Failed lots rejected at the gate — never blended.

IPQC — In-Process

Line operators run weight, fill-volume and seal-integrity checks hourly. Environmental monitoring in cleanrooms is continuous. Deviations stop the line, not the shipment.

OQC — Outgoing

Final release batch: Agilent HPLC chemistry, micro testing, and visual inspection under light. Only then is the COA issued and the lot cleared to ship.

Registrations

Class II — 15 registered products

All numbers verifiable on the NMPA public database. Certificates scanned copies available on request.

Product	Registration No.	Valid Until
Medical Recombinant Type III Human-like Collagen Liquid Dressing (Ampoule)	湘械注准20222141159	2027-06-23
Medical Recombinant Type III Human-like Collagen Gel Dressing	湘械注准20222141157	2027-06-21
Medical Recombinant Type III Human-like Collagen Dressing Patch	湘械注准20222141156	2027-06-21
Hyaluronic Acid Gel Dressing	湘械注准20212140487	2026-04-12
Liquid Wound Dressing	湘械注准20232140655	2028-07-23
Liquid Dressing	湘械注准20232140552	2028-06-24
G-Type Oligoalginate Liquid Dressing	湘械注准20232140941	2028-09-24
Recombinant Collagen Repair Dressing	湘械注准20232141306	2028-12-27
Recombinant Collagen Repair Dressing (Freeze-Dried Powder A + Solvent B Kit)	湘械注准20232141300	2028-12-27
Medical Recombinant Collagen Complex Solution	湘械注准20242140563	2029-07-02
Medical Sodium Hyaluronate Complex Solution (Vials 1/3/5/7/10 mL)	湘械注准20242140524	2029-06-23
Mussel Adhesive Protein Nasal Spray	湘械注准20242140588	2029-07-08
Sodium Carboxymethyl Cellulose Liquid Dressing	湘械注准20242141057	2029-11-04
Silk Fibroin Liquid Dressing	湘械注准20252140341	2030-04-06
Medical Gynecological Gel	湘械注准20242180391	2029-05-21

Class III

Even the needles are ours

Product	Registration No.	Valid Until
Single-Use Sterile Injection Needle	国械注准20243142419	2029-11-28

A Class III registration is the highest device class in China. For our brand partners it means the whole supply chain — down to the sharpest component — stays inside one audited quality system.

Class I — Filed

Six filed adjunct products

Product	Filing No.
Cell Preservation Solution	湘潭械备20230003号
Single-Use Skin Prick Device	20230014号
Cleaning Solution	20230010号
Cotton Pads	20230053号
Medical Care Kit	20240029号
Medical Cooling Gel	湘株械备20210015号

Management System

Certified, not self-declared

ISO 13485

Medical device quality management system — audited by a third party.

Class II + III Licenses

Medical device production licenses for both classes.

National High-Tech Enterprise

State-recognized R&D capability; 4 invention + 10 utility patents.

Specialized SME (Provincial)

Hunan "specialized & sophisticated" enterprise designation.

Compliance note: we manufacture post-procedure skincare and wound-care devices. We do not claim FDA or CE approval, and we do not market injectable fillers. Claims for your market are your decision — we supply the compliant base copy.