FondCircle M1-L50
FondCircle M1-L50 is a Class II device made by FondCircle Inc., listed in FDA GUDID since 10 Mar 2025 (UDI-DI 00850070979184), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850070979184 | Date10 Mar 2025 | StatusListed |
Official records
- AccessGUDID record 00850070979184
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- FondCircle
- Generic name
- Blood lancing device tip
- Model / reference
- M1-L50
- Primary DI / UDI-DI
- 00850070979184
- FDA product code
- QRL
- GMDN term
- Blood lancing device tip
- Device class
- Class II
- Regulation number
- 878.4850
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).
- Lancing device by Tianjin Huahong Technology Co., Ltd.
- Medifun Lancing Device Model LD-E1 by Medifun Corporation
- Lancing System, Sterile Lancet for Single Use, Lancing Device by Shandong Lianfa Medical Plastic Products Co.,Ltd.
- Facet Blood Lancets by Facet Technologies, LLC.
- TD-5010 Lancing Device and TD-5084 Sterile Lancets by Gostar Co., Ltd.
- Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) by Tianjin Huahong Technology Co., Ltd.
- LDE4 Lancing Device by i-SENS, Inc.
- Facet Manatee Reusable Lancing Base by Facet Technologies, LLC.
- Accu-Chek Softclix Blood Lancing System by ROCHE DIABETES CARE, INC.
- Accu-Chek FastClix Blood Lancing System by ROCHE DIABETES CARE, INC.