Contract manufacturerACME-MONACO CORP. (Presque Isle, ME)MaineCardiovascularDentalClass IIClass I
ACME-MONACO CORP.
Contract manufacturer · Presque Isle, ME
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1222301 (openFDA record; or search FDA's registration database)
- FEI number
- 1000121071
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- ACME-MONACO CORP. (FDA owner/operator no. 1293141)
- Registered address
- 1450 Central Drive, Presque Isle, ME 04769
- Contract listings
- 6 device listings, 6 product codes, first listed Aug 6, 1992
- 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 |
|---|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract manufacturing | Nov 27, 2007 |
| DRB | Stylet, Catheter | Class II | Cardiovascular | Contract manufacturing | Nov 27, 2007 |
| DZC | Wire, Orthodontic | Class I | Dental | Contract manufacturing | Aug 6, 1992 |
| ECN | Clamp, Wire, Orthodontic | Class I | Dental | Contract manufacturing | Aug 6, 1992 |
| ECO | Spring, Orthodontic | Class I | Dental | Contract manufacturing | Aug 6, 1992 |
| EJF | Bracket, Metal, Orthodontic | Class I | Dental | Contract manufacturing | Aug 6, 1992 |