Spellman High Voltage Electronics GmbH
DE-MF-000014609 · Germany · Bochum
Spellman High Voltage Electronics GmbH is registered in the European database on medical devices as a manufacturer, with 297 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 297 |
|---|
Devices declared under this manufacturer
- EDITOR HFe 401
- EDITOR HFe 501
- EDITOR HFe 601
- EDITOR HFe 801
- OptiX HF 60
- PROVARIO HF 40
- PROVARIO HF 50
- PROVARIO HF 60
- PROVARIO HF 80
Showing 12 of 297 declared devices.
Catalogue references include 031400105-BA-I, 031400108-24V, 07002103, 07003403-001, 07003501-002, 07003601-002.
European nomenclature codes declared: Z11039011.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPELLMAN HIGH VOLTAGE ELECTRONICS CORP. (US) · FDA 2429877 |
| Devices in EUDAMED | 297 |
| Country of registration | Germany |
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. Spellman High Voltage Electronics GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI25/00000027 | issued | 2030-04-03 |