Weihai, China – October 29, 2026 -- Nine of the 20 labelers in the FDA's GUDID database for topical tissue adhesives hold no clearance of their own, yet they account for 44 of 97 device records (45%), according to a September 2026 supplier-landscape report from VEMERIX, the international brand of Weihai Medison Medical Equipment Co., Ltd. The company has distilled the findings into a document checklist for buyers sourcing medical cyanoacrylate adhesives in bulk.
US clearances concentrate in 14 applicant groups, four of which hold 23 of 36
The report counts 36 FDA 510(k) clearances under product code MPN (topical tissue adhesives) between December 2008 and September 2025. Four companies hold 23 of them. The 45% figure reflects lawful private-label and relabeling arrangements, through which much of the category reaches the market, and describes traceability rather than compliance.
EU registrations trace to six manufacturers, led by China and the US
The EU database lists 44 topical records from just six manufacturers. China is the registered origin country on 17 records and the US on 15.
China splits skin adhesives into Class III and liquid dressings into Class II
China's catalogue places skin adhesives at Class III (code 02-13-09) and liquid dressings for non-chronic wounds at Class II (14-10-08). The line runs between surgical closure and suture replacement on one side and superficial, assistive wound care on the other. The country's UDI database resolves 239 adhesive records to only 32 registrations.
A skin-closure product cannot inherit another product's vascular or internal-surgical claim because both are cyanoacrylates, the report states. "Class II" also carries a different meaning in each market.
Checklist sets five document requests for first supplier contact
- The exact product name and model of the adhesive to be supplied
- The legal manufacturer identified on the product labeling
- For a relabeled product, the clearance or registration holder standing behind it
- The certificate's approved scope, matched against the claim the buyer intends to make
- Current regulatory documents for the destination market
VEMERIX applies the same test to its own skin adhesive
VEMERIX's entry in the category is the Cyanoacrylate Medical Skin Adhesive, a single-use product in its Wound & Skin range for aiding closure of small, non-chronic wounds. Registration and documentation are addressed product by product in each supply discussion. The company works as both a legal manufacturer and a private-label partner. It claims no new clearance, no portfolio-wide approval and no equivalence to any other manufacturer's adhesive.
Founder Lily (Lianhua) Nan said, "A buyer who can trace the legal manufacturer behind a brand is a stronger customer for everyone in the chain."
The counts describe register records as of the report's snapshot, not sales or current market availability. The report draws on the FDA 510(k) database, FDA GUDID, EUDAMED, China's NMPA UDI database and UN trade data for HS 3006.10. It was published Sept. 14, 2026.