FUJIFILM medwork GmbH
DE-MF-000008444 · Germany · Höchstadt a.d. Aisch
FUJIFILM medwork GmbH is registered in the European database on medical devices as a manufacturer, with 251 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 137 |
|---|---|
| Class IIb | 114 |
Most frequent device types declared: BIO1-C4-18-120, BIO1-H4-23-230, FOR1-N1-30-220, INJ1-A1-05-5-18-180, INJ1-A3-07-5-18-240.
Among these devices, 233 are declared sterile, 114 active.
Devices declared under this manufacturer
- BAL1-D3-15-35-200
- BIO1-C4-18-120
- CLE1-G1-50-18-180
- CLE1-KIT2-COLO
- INJ1-A1-05-5-18-180
- LIT1-C3-25-23-200
- LIT2-D-HAN
- PAP1-A1-20-OL
- PAP1-C7-20-E35-OL
- PAP1-C8-30-35-OL
- PAP1-D7-20-35
- PAP1-S8-25-25-S2
Showing 12 of 251 declared devices.
Catalogue references include 70100146600, 70100146651, 70100146708, 70100147806, 70100147815, 70100166445.
European nomenclature codes declared: G03040299, G03040202, G03030102, G0308010101, G03020101, G99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FUJIFILM medwork GmbH (DE) · FDA 3020707080 |
| Devices in EUDAMED | 251 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 251 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 0.8 % |
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. FUJIFILM medwork GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000297126 | supplemented | 2028-10-01 |