MedtechSourcebook

ASSEMBLY REQUIRED DI

Contract manufacturer ยท Mount Sinai, NY

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

FDA registration
2437956 (openFDA record; or search FDA's registration database)
FEI number
3002357954
Registered for
FDA registration year 2027
Establishment types
Contract manufacturer; Repackager or relabeler
Owner or operator
ASSEMBLY REQUIRED DIST. (FDA owner/operator no. 9031473)
Registered address
5507 Nesconset Hwt. #10, Ste 336, Mount Sinai, NY 11766
Contract listings
1 device listings, 1 product codes, first listed Jun 11, 2013
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
OHYPill Crusher/CutterClass IGeneral hospitalContract manufacturingJun 11, 2013