FDA device listing
MICROLET®NEXT Lancets
FDA device listing 1998431943 · Ascensia Diabetes Care Holdings AG
Key facts
| Proprietary names | MICROLET®NEXT Lancets |
|---|---|
| Owner/operator | Ascensia Diabetes Care Holdings AG |
| Owner/operator number | 10050965 |
| Premarket submissions | K241810 |
| Product codes | QRK |
| Device names | QRK - Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4850 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ASCENSIA DIABETES CARE HOLDINGS AG, Ascensia Diabetes Care Poland Sp. z o.o., Ascensia Diabetes Care US Inc. |
| Establishment registrations | 1810909, 3011121740, 3012118659, 3038419886 |
| FEI numbers | 1810909, 3010700165, 3012118659, 3038419886 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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