MedtechSourcebook

Datascope Corp

Contract manufacturer ยท Wayne, NJ

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

FDA registration
3007965489 (openFDA record; or search FDA's registration database)
FEI number
3007965489
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Datascope Corp. (FDA owner/operator no. 2221819)
Registered address
45 Barbour Pond Drive, Wayne, NJ 07470
Contract listings
10 device listings, 1 product codes, first listed Dec 6, 2007
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
DSPSystem, Balloon, Intra-Aortic And ControlClass IICardiovascularContract manufacturingDec 6, 2007