HomeUSAChemence Medical Products, Inc.

Chemence Medical Products, Inc.

USA · Alpharetta
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
7listed device types
Class I 4Class II 2Class III 1
plus 17 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States17 registration records, 8 510(k), 0 PMA
Manufacturer names merged into this page: CHEMENCE MEDICAL INC. · CHEMENCE MEDICAL, INC. · CHEMENCE MEDICAL, LLC
Same-named companies — This database also contains companies with near-identical names: Chemence Medical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Alpharetta

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12006 · K050757
12010 · K101276
22016 · K162352
12017 · K171442
22020 · K200264
12021 · K212246

FDA listed device types

Cutaneous Tissue Adhesive With Mesh 1Tissue Adhesive For The Topical Approximation Of Skin 1Tape And Bandage, Adhesive 1Bandage, Liquid 1Solvent, Adhesive Tape 1Bandage, Liquid, Skin Protectant 1Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212246Exofin Precision Pen2021-09-09
USK200264Exofin High Viscosity Topical Skin Adhesive2020-12-17
USK191461Exofin Fusion Skin Closure System2020-06-05

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