Spiegelberg GmbH & Co. KG
DE-MF-000000008 · Germany · Hamburg
Spiegelberg GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 33 |
|---|---|
| Class IIa | 5 |
Most frequent device types declared: ELD33.010.02, EVD30.001.01/FV800P, EVD30.030.01, EVD30.030.02, ICP.1.ST.
Among these devices, 36 are declared sterile, 2 active, 2 with a measuring function.
Devices declared under this manufacturer
- External Ventricular Drainage Set
- Probe 3PN
- Probe 3PS
- Silverline® Lumbar Drainage Catherter
- Silverline® Ventricular Drainage Catheter 10F
- Silverline® Ventricular Probe 10F
- Ventricular Drainage Catheter 10F
- Ventricular Drainage Catheter 10F with Cranial Bolt
- Ventricular Drainage Catheter 12F with Cranial Bolt
- Ventricular Drainage Catheter 8F
- Ventricular Drainage Catheter 8F with Cranial Bolt
- Ventricular Probe 10F
Showing 12 of 38 declared devices.
Catalogue references include ELD33.010.02, EVD30.001.01/FV800P, EVD30.030.01, ICP.1.08.02, ICP.1.10.01, NKT.1.08.01.
European nomenclature codes declared: Z12039001, A0601010402,N010399, A0601010402,N010399,Z12039001, A0601010201,A060301,N010303, A0601010201,N010303, N020302.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPIEGELBERG GmbH & Co. KG (DE) · FDA 3002108226 |
| Devices in EUDAMED | 38 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 38 |
|---|---|
| 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: United States only. Spiegelberg GmbH & Co. KG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000265951 | issued | 2030-10-22 |
1000265927 | issued | 2029-03-20 |
1000216002 | issued | 2030-03-12 |
1000210544 | issued | 2029-03-20 |