HumanOptics Holding AG
DE-MF-000017892 · Germany · Erlangen
HumanOptics Holding AG is registered in the European database on medical devices as a manufacturer, with 177 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 177 |
|---|
Among these devices, 177 are declared sterile, 177 implantable.
Devices declared under this manufacturer
- Artificial Iris FiberFree Standard Dark Brown
- Aspira-aAY+ 15.0
- Aspira-aAY+ 23.0
- Aspira-aAY+ 8.0
- Aspira-aAY+ SL 15.0
- Aspira-aAY+ SL 17.0
- Aspira-aAY+ SL 17.5
- Aspira-aAY+ SL 18.5
- Aspira-aAY+ SL 24.5
- Aspira-aAY+ SL 27.0
- Aspira-aAY+ SL 6.0
- Torica-aA 15.5 cyl+9.5
Showing 12 of 177 declared devices.
Catalogue references include 00041100, 00041200, 00086300, 00086350, 00088500, 00089100.
European nomenclature codes declared: P030102090202, P0399, P030102090302, P030102100302, P030102100202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HUMANOPTICS HOLDING AG (DE) · FDA 3010531293 |
| Devices in EUDAMED | 177 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 177 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 1.7 % |
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. HumanOptics Holding AG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44912221836 | supplemented | 2030-06-12 |
44911221836 | supplemented | 2030-06-12 |