Data / Medical devices / Singapore / Acme Monaco Asia Pte. Ltd.
Acme Monaco Asia Pte. Ltd.: FDA-registered device maker in Singapore Central Singapore, Singapore, 1 510(k) clearance
Acme Monaco Asia Pte. Ltd. is registered with the FDA (registration 3007064586) in Singapore Central Singapore, Singapore. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 1992. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007064586
- Address
- 1 Genting Link, No. 04-05/06 Perfect One, Singapore Central Singapore, Singapore, 349518
- Owner or operator
- ACME-MONACO CORP. (1293141)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2026
- Brand names listed
- Multiple
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 1992 | K920884 | GUIDEWIRES, VARIOUS TYPES | DQX | Substantially Equivalent | Acme-Monaco Corp. | accessdata.fda.gov |
Compare with other makers
Updated August 19, 1992. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.