# European Custom Manufacturing BV

- Location (FDA's records): Gemert, NL
- FDA decisions: 2 (2004–2008): 2 510(k) clearances
- Product codes: LDF (1), DSA (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cp Medical: 1 (https://510kreport.com/company/cp-medical)

## Firms that cite its devices most
- Atrility Medical, LLC: 1 (https://510kreport.com/company/atrility-medical)

## Its most-cited devices
- K080621: Fastlock, Model PC175M01, PC175MCE, PC005R01 (2008), cited by 1

## Recent decisions
- K080621: Fastlock, Model PC175M01, PC175MCE, PC005R01 (Apr 29, 2008)
- K033858: Temporary Bipolar Myocardial Pacing Wire (Jul 12, 2004)

Source page: https://510kreport.com/company/european-custom-manufacturing