Medifun Lancing Device Model LD-E1
510(k) K231797
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK231797 | Date22 Nov 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Medifun Lancing Device, Model No. LD-E1
- 510(k) Number
- FDA Product Code
- QRL
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4850
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Medifun Lancing Device Model LD-E1 is a multiple-use blood lancet designed for single-patient use only, classified as a Class II medical device. It is intended for controlled skin punctures to facilitate blood sampling or glucose monitoring, adhering to safety standards for reusable lancets in clinical settings.
This device is supplied sterile and intended for reuse with a single patient only, as indicated by its regulatory classification. It complies with FDA 510(k) clearance and EU MDR requirements, with a registration number of 1066444. The lancet is intended for use in general and plastic surgery settings, though its primary function remains blood sampling or glucose monitoring. Storage and handling must follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Medifun Corporation
Questions
AI-generated answers, 18 Sep 2026
Is this lancing device intended for repeated use across multiple patients, or is it single-patient only?
The Medifun Lancing Device (Model LD-E1) is explicitly designed as a multiple-use device for single-patient use only. While it can be reused within the same patient’s care, it is not intended for sharing between different patients, aligning with its regulatory classification as a Class II device for controlled skin punctures in clinical settings.
How should I store this device to maintain its sterility and functionality?
The device is supplied sterile, so storage must follow manufacturer guidelines to preserve sterility and functionality. Since it is reusable for a single patient, it should be stored in a clean, dry environment—preferably in its original packaging or a sealed container—until first use. After use, it should be cleaned and stored according to the manufacturer’s instructions to prevent contamination before reuse with the same patient.
What regulatory pathways does this device follow, and how does that affect its use?
The Medifun Lancing Device (Model LD-E1) holds FDA 510(k) clearance and complies with EU MDR requirements, with registration numbers listed in the data. Its classification as a Class II device and the advisory committee designation (SU) indicate it underwent a traditional review process for safety and performance. Clinically, this means it meets established standards for reusable lancets in controlled settings like general or plastic surgery, though its primary use remains blood sampling or glucose monitoring.
Are there different sizes or models available for this lancing device, or is it a single configuration?
The provided data does not specify multiple sizes or models for the Medifun Lancing Device (Model LD-E1). It is described as a singular device (Model No. LD-E1) with no variations mentioned, so it appears to be a single configuration designed for general use in blood sampling or glucose monitoring.