FDA device listing
CENTRIC 250 120V,CENTRIC 250 IVD 120V,CENTRIC 260 120V,CENTRIC 260 R 120V,CENTRIC 350 120V,CENTRIC 350 IVD 120V,CENTRIC…
FDA device listing 2072105451 · Domel, d.o.o., (Business Unit LABS)
Key facts
| Proprietary names | CENTRIC 250 120V,CENTRIC 250 IVD 120V,CENTRIC 260 120V,CENTRIC 260 R 120V,CENTRIC 350 120V,CENTRIC 350 IVD 120V,CENTRIC 400 R 120V,CENTRIC CF 108 GR 120V,CENTRIC CF 108 R 120V,CENTRIC CF 220 120V,CENTRIC CF 220 IVD 120V,CENTRIC CF 48 120V,CENTRIC CF 48 R 120V,CENTRIC MF 220 120V,CENTRIC MF 220 IVD 120V,CENTRIC MF 48 120V,CENTRIC MF 48 IVD 120V,CENTRIC MF 48 R 120V,CENTRIC MF 48 R IVD 120V |
|---|---|
| Owner/operator | Domel, d.o.o., (Business Unit LABS) |
| Owner/operator number | 10091982 |
| Product codes | JQC |
| Device names | JQC - Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | Domel, d.o.o., (Business Unit LABS) |
| Establishment registrations | 3015651306 |
| FEI numbers | 3015651306 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database