SPIGGLE & THEIS Medizintechnik GmbH
DE-MF-000006647 · Germany · Overath
SPIGGLE & THEIS Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 30 |
|---|
Most frequent device types declared: ENT-single-use suction tubes, Injection needles and trocars, Sterilisation container.
Among these devices, 3 are declared sterile, 26 reusable.
Devices declared under this manufacturer
- Injection needle
Showing 12 of 30 declared devices.
Catalogue references include 11000-D30, 11000-D55, 11000-D75, 12000-D15, 12000-D40, 12000-D50.
European nomenclature codes declared: P020180, A060102, L030199, S010401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPIGGLE & THEIS MEDIZINTECHNIK GMBH (DE) · FDA 3002858762 |
| Devices in EUDAMED | 30 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 16.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SPIGGLE & THEIS MEDIZINTECHNIK GMBH |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| Class 3 devices | 1 |
| First licensed | 2012-02-16 |
Licence types: Device Family (12), System (2).
Licensed under: TUBAVENT BALLOON CATHETER, ENDOSCOPE, SUCTION TUBES AND INSTRUMENTS, HF-INSTRUMENTS, HANDLES FOR SUCTION TUBES, SURGICAL LARYNGOSCOPES.
North American profile: Both markets. SPIGGLE & THEIS Medizintechnik GmbH is registered in both the United States and Canada.