FDA device listing
9MPS2BILAN: MacoPress Smart Smarter and DMS Ethernet Module - with breaker module for main press,9MPS2BIWIFI: MacoPress…
FDA device listing 1213232986 · MACO PHARMA
Key facts
| Proprietary names | 9MPS2BILAN: MacoPress Smart Smarter and DMS Ethernet Module - with breaker module for main press,9MPS2BIWIFI: MacoPress Smart Smarter and DMS WIFI Module - with breaker module for main press,9MPS2BRLAN: MacoPress Smart Smarter and DMS Ethernet Module - no breaker,9MPS2BRWIFI: MacoPress Smart Smarter and DMS WIFI Module - no breaker |
|---|---|
| Owner/operator | MACO PHARMA |
| Owner/operator number | 9067788 |
| Premarket submissions | BK180306 |
| Product codes | KSS |
| Device names | KSS - Supplies, Blood-Bank |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.9050 |
| Review panels | Hematology |
| Registered establishments | MACO PHARMA, MACOPRODUCTIONS S.A.S. |
| Establishment registrations | 9710488, 3004404323 |
| FEI numbers | 3004404323, 3005138167 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Foreign Private Label Distributor |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database