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Safety Lancet
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 94-4918-21SModel PA 21G 1.8mmRef LF-AD-23Model APA 23G510(k) K222376
Identity
- Device Name
- Safety Lancet EUDAMED
- Model / Reference
- PA 21G 1.8mm EUDAMED94-4918-21S EUDAMEDAPA 23G EUDAMEDLF-AD-23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949517006652 EUDAMED06949517006218 EUDAMED
- Basic UDI-DI
- B-06949517006652 EUDAMEDB-06949517006218 EUDAMED
- 510(k) Number
- K222376 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Market of Registration
- Poland EUDAMEDItaly EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Safety Lancet by Shandong Lianfa Medical Plastic Products Co., Ltd. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06949517006652 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222376 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06949517006652 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Lianfa Medical Plastic Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000028790
- Authorised Representative
- Linkfar Healthcare GmbH DE-AR-000005107
Sources (3)
- EUDAMED 66b0ee73-0c01-4cad-a95d-b6790f95bd28 61 fields · synced Oct 6, 2026
- EUDAMED 9521125e-d99c-45cc-a0c7-5cef7324bde9 61 fields · synced May 17, 2026
- FDA 510(k) K222376 24 fields · synced May 18, 2026