Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
SteriLance Medical (Suzhou), Inc. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Suzhou
- Advisory committee description
- General, Plastic Surgery
- Address 1
- #168 Putuoshan Rd.
- Address 2
- New District
- Statement or summary
- Summary
- Product code
- QRK
- Zip code
- 215153
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Decision date
- 2026-08-25
- Decision code
- SESE
- Country code
- CN
- Device name
- Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
- Advisory committee
- SU
- Contact
- Susan Sun
- K number
- K262631
- Date received
- 2026-07-29
- Review advisory committee
- SU
- Postal code
- 215153
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4850
- Device class
- 2
- Registration number
- 3009171251, 1832216, 3007382160, 1810909, 3011420269, 3044026004, 3011065399, 3003741676, 3004143450, 2954323, 3006755541, 3017500903, 9613304, 3013223546, 3008102042, 3025413691, 3011806823, 3006899020, 3038419886, 3005798905, 3024273968, 3011213605, 3021186226, 3004130086, 1058955, 3005644014, 3021611414, 3004637226, 3017520431, 3006142663, 3030626362, 1066444, 3008780388, 2416465, 1832816, 8031690, 3007363438, 3011617315, 3004146366, 1058602 +43 more
- FEI number
- 1832216, 3007382160, 3010700165, 3003405786, 1810909, 3011420269, 3044026004, 3011065399, 3003741676, 3004143450, 3006755541, 3017500903, 3013223546, 3025413691, 3011806823, 3000191104, 3006899020, 3038419886, 3005798905, 3024273968, 3011213605, 3008801456, 3021186226, 3004130086, 3005644014, 3021611414, 3011774813, 3004637226, 3017520431, 3006142663, 3030626362, 3008780388, 2416465, 1832816, 3011617315, 3004146366, 3006759904, 3020976354, 3011191255, 3012118659 +43 more