MACO PHARMA
FR-MF-000001657 · France · MOUVAUX
MACO PHARMA is registered in the European database on medical devices as a manufacturer, with 216 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 186 |
|---|---|
| Class IIa | 30 |
Most frequent device types declared: 9MSLIGHT00, LXTFLW01.
Among these devices, 207 are declared sterile, 5 active.
Devices declared under this manufacturer
- BLADE CARTRIDGE
- MACONNECT
- Maco PLAS4 Holder
- MacoFlow Restrictor
- MacoGenic Set
- MacoSeal LIGHT
- MacoSeal PS2-AS
- MacoSeal UV
- MacoTronic UV
- Thromboflex
Showing 12 of 216 declared devices.
Catalogue references include ABS0734EU, FQE6287LU, GSR0501AU, LQT6287LU, MQE6287LN, MSC1208DU.
European nomenclature codes declared: B0101020101, B010201, B0101020201, B010199, B0101020299, B0101020102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MACO PHARMA (FR) · FDA 3004404323 |
| Devices in EUDAMED | 216 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 216 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 0.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MACOPHARMA |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| First licensed | 2001-05-28 |
Licence types: Device Family (3), Device Group Family (2), Single Device (1).
Licensed under: POCHES DESTINEES AU PRELEVEMENT ET A LA TRANSF, MACOPRESS SMART AUTOMATIC BLOOD COMPONENTS SEP, POCHES A SANG, POCHES DE TRANSFERT, MACO BIOTECH FREEZING EVA BAGS, TRANSFER TUBING.
North American profile: Both markets. MACO PHARMA is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40558 | supplemented | 2031-06-24 |
39531 | amended | 2029-01-16 |