European Custom Manufacturing BV
Country not established
- Devices
- 2
What European Custom Manufacturing BV makes
European Custom Manufacturing BV produces temporary bipolar myocardial pacing wires and FastLock catheter models (PC175M01, PC175MCE, PC005R01), designed for short-term cardiac pacing and lead fixation in clinical settings.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates from the US.
Catalogue
Temporary Bipolar Myocardial Pacing Wire Ref K033858
Regimes: 510(k) Registry: 510(k)Fastlock, Model PC175M01, PC175MCE, PC005R01 Ref K080621
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does European Custom Manufacturing BV have in the registry?
The registry currently lists 2 devices for European Custom Manufacturing BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list European Custom Manufacturing BV's devices?
Among its 2 most recently registered devices, European Custom Manufacturing BV has devices listed in FDA 510(k) (2 devices).
What risk classes do European Custom Manufacturing BV's devices fall under?
Among its 2 most recently registered devices, the classes recorded for European Custom Manufacturing BV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from European Custom Manufacturing BV in the registry?
The most recently registered devices listed for European Custom Manufacturing BV include TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE and FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01.