Contract manufacturerHeraeus Medical Components Caribe, Inc. (Dorado, PR)Puerto RicoCardiovascularClass IIClass III
Heraeus Medical Components Caribe, Inc.
Contract manufacturer ยท Dorado, PR
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3005029049 (openFDA record; or search FDA's registration database)
- FEI number
- 3005029049
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Heraeus Medical Components, LLC (FDA owner/operator no. 10049892)
- Registered address
- 415 ROAD 693, Dorado, PR 00646
- Contract listings
- 4 device listings, 4 product codes, first listed Dec 22, 2016
- 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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DRB | Stylet, Catheter | Class II | Cardiovascular | Contract manufacturing | Dec 22, 2016 |
| DTB | Permanent Pacemaker Electrode | Class III | Cardiovascular | Contract manufacturing | Aug 10, 2022 |
| DTD | Pacemaker Lead Adaptor | Class II | Cardiovascular | Contract manufacturing | Aug 10, 2022 |
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Class III | Cardiovascular | Contract manufacturing | Aug 10, 2022 |