Henke-Sass, Wolf GmbH
DE-MF-000005531 · Germany · Tuttlingen
Henke-Sass, Wolf GmbH is registered in the European database on medical devices as a manufacturer, with 263 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 263 |
|---|
Among these devices, 17 are declared reusable.
Devices declared under this manufacturer
- ARTHROSCOPE
- ARTHROSCOPIC SURGERY DILATORS
- ARTHROSCOPIC SURGERY TROCAR
- CYSTOSCOPE
- Cystoscope
- HYSTEROSCOPE
- Hysteroscope
- LAPAROSCOPE
- LARYN 6/70° 159 AK HM HSW
- LARYNGOSCOPES
- Laryngoscope
- OTOSCOPES
Showing 12 of 263 declared devices.
Catalogue references include 8300006492, 8300058668, 8300059308, 8300067435, 8300067440, 89550265-01.
European nomenclature codes declared: Z12021008, Z12029009, Z12021101, Z12020704, L031204, L031280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HENKE-SASS WOLF, GMBH. (DE) · FDA 8010418 |
| Devices in EUDAMED | 263 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 263 |
|---|---|
| Found in the U.S. device database | 28 |
| Share | 10.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HENKE-SASS WOLF GMBH |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| First licensed | 2012-11-20 |
Licence types: Device Family (10), System (2), Single Device (1).
Licensed under: HENKE-JECT NEEDLES FOR SINGLE USE, STERILE SINGLE-USE SYRINGES, PRECISION S HYDROFLOW CLEANING SHEATH, ARTHROSCOPE AUTOCLAVABLE, OPTICAL FORCEPS, OBTURATOR.
North American profile: Both markets. Henke-Sass, Wolf GmbH is registered in both the United States and Canada.