SPENGLER SAS
FR-MF-000041197 · France · Aix-en-Provence
SPENGLER SAS is registered in the European database on medical devices as a manufacturer, with 201 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 201 |
|---|
Most frequent device types declared: Manual pneumatic tourniquet, NIBP Cuff, Tourniquet cuff.
Devices declared under this manufacturer
- Brassard PNI LIAN® nylon gris raccord vis mâle enfant (S)
- Brassard PNI LIAN® nylon gris raccord vis mâle extra large ad. (XL)
- Brassard PNI Soft Cuff® 2 poches adulte (26-33cm) DDM
- Brassard PNI Soft Cuff® nourrisson (6-12cm) DDM
- Brassard PNI immergeable CLINIC® large adulte (33-41cm)
- Brassard PNI immergeable CLINIC® nourrisson (6-12cm)
- Brassard garrot monobloc droit adulte 8x46cm DDM sangle
- Cuissard garrot autoclavable droit adulte 9x72cm DDM
- Cuissard garrot autoclavable droit adulte L 9x85cm DDM
- Cuissard garrot autoclavable droit petit adulte 6x56cm DDM
- Cuissard garrot monobloc conique adulte XL 10x82cm DDM sangle
- Garrot Manupump® Cuissard monobloc conique adulte XXL 10x107cm DDM
Showing 12 of 201 declared devices.
Catalogue references include 334191, BM101S, BM105S, BT101, GBDMS104, GCS103.
European nomenclature codes declared: Z1203020302, C9005, Z12139006, V9003, Z12030399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 201 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 201 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. SPENGLER SAS was not found in either the U.S. or the Canadian register.