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Lite3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05-112618Ref 05-112124Ref 05-112818Ref 05-111818BRef 05-112824
Identity
- Trade Name
- Lite3 EUDAMEDSteriLance Lite3 Safety Lancet 30G 1.5mm FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- Disposable Safety Lancets EUDAMED
- Model / Reference
- 05-112618 EUDAMED05-112124 EUDAMED05-112818 EUDAMED05-111818B EUDAMED05-112824 EUDAMED05-093015 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16945630124126 EUDAMED16945630124140 EUDAMED16945630116978 EUDAMED16945630124133 EUDAMED16945630116947 EUDAMED16945630123174 FDA UDI
- Basic UDI-DI
- 6945630105BH EUDAMED
- Unit of Use DI
- 06945630124129 EUDAMED06945630124143 EUDAMED06945630116971 EUDAMED06945630124136 EUDAMED06945630116940 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Manual blood lancing device, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood lancet, single-use
Lite3 by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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- Twist Lancet (23G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6945630105BH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (6)
- EUDAMED e1a188cd-b5d0-47d6-8808-a3d5fc43fdcb 61 fields · synced Aug 3, 2026
- EUDAMED 9ab7f20a-1952-4c7c-9e69-02220c45d94c 61 fields · synced May 17, 2026
- EUDAMED ab5d7f0a-c28d-49b2-963a-d707d24e775f 61 fields · synced May 18, 2026
- EUDAMED 6cf159de-9b2b-4571-bcad-babc87817260 61 fields · synced May 19, 2026
- EUDAMED be3582da-0254-4cc7-ab81-2bbe98767a90 61 fields · synced May 19, 2026
- FDA UDI 93404192-3378-4384-8fb8-a603a2b74d4e 32 fields · synced May 25, 2026