The Surgical Company International B.V.
NL-MF-000001973 · Netherlands · Almelo
The Surgical Company International B.V. is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 56 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: 650200, 660300, 660500-B, 670800-B, 671700.
Among these devices, 19 are declared sterile, 5 active.
Devices declared under this manufacturer
- Fluido® Compact Warming Module
- Fluido® Irrigation Female Connector
- Fluido® Irrigation Male Connector
- Fluido® Pressure Chamber
- Fluido® Trauma Plus Set
- Fluido®Irrigation URO Set
- Mistral-Air® Adult Plus
- Mistral-Air® Half Underbody Plus
- Mistral-Air® Paediatric Underbody Plus
- Mistral-Air® Premium Half Underbody
- Mistral-Air® Premium Warming Suit M
- Mistral-Air® Surgical Access Plus Sterile
Showing 12 of 58 declared devices.
Catalogue references include 650200, 660300, 670800-B, 680911, MA1620, MA2220.
European nomenclature codes declared: T030301, Z12030385, Z12030380, V0899, Z12030305.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | The Surgical Company International B.V. (NL) · FDA 3038241934 |
| Devices in EUDAMED | 58 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 58 |
|---|---|
| Found in the U.S. device database | 42 |
| Share | 72.4 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. The Surgical Company International B.V. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2259019CE03 | amended | 2027-06-10 |
2259019CE02 | amended | 2027-06-10 |
2259019CE01 | supplemented | 2027-06-10 |