Stille AB
Active in EUDAMEDSwedenfrom SRN EUDAMED FDA SRN SE-MF-000001228 FEI 3003696170
- Devices
- 1,124
- Registrations
- EUDAMEDFDA
- FDA recalls
- 4
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 1,124 devicesShowing 1-50 of 1,124
Company details
- EUDAMED SRN
- SE-MF-000001228
- FDA FEI number
- 3003696170
- DUNS number
- 355280827
- EU VAT number
- SE556249484801
- EUDAMED status
- Active
- EUDAMED registered name
- Stille AB
- Registered address
- 11, Ekbacken, 64430, Torshälla, Sweden
- Website
- www.stille.se
- [email protected]
- Phone
- +46 72 402 34 14
- PRRC contact
- Katalin Daroczy
FDA recalls
2009
- 3 Nov 2009 Z-0564-2010 Unclassified (pre-2012) Terminated There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.
- 3 Nov 2009 Z-0565-2010 Unclassified (pre-2012) Terminated There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.
- 3 Nov 2009 Z-0566-2010 Unclassified (pre-2012) Terminated There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.
2008
- 27 Aug 2008 Z-0119-2009 Unclassified (pre-2012) Terminated The table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w
Frequently asked questions
How many devices does Stille AB have in the registry?
The registry currently lists 1124 devices for Stille AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stille AB's devices?
Among its 50 most recently registered devices, Stille AB has devices listed in EUDAMED (6 devices) and FDA GUDID (44 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Stille AB's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Stille AB's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Stille AB?
FDA recall records list 4 recalls initiated by Stille AB, the most recent initiated on 3 Nov 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Stille AB in the registry?
The most recently registered devices listed for Stille AB include Medstone detachable side rail EU W, Medstone detachable side rail EU KIT W, Side rail non symmetrical KIT EU W and Medstone detachable side rail KIT EU.