MedtechSourcebook

HK KOLMAR USA, LLC

Contract manufacturer ยท Olyphant, PA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1000221288 (openFDA record; or search FDA's registration database)
FEI number
1000221288
Registered for
FDA registration year 2026
Establishment types
Specification developer; Manufacturer; Contract manufacturer
Owner or operator
HK Kolmar USA LLC (FDA owner/operator no. 10094868)
Registered address
102-300 Life Science Drive, Olyphant, PA 18447
Contract listings
1 device listings, 1 product codes, first listed Dec 30, 2025
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
NECBandage, Liquid, Skin ProtectantClass IGeneral hospitalContract manufacturingDec 30, 2025