Identity
- Trade Name
- SteriLance EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMED
- Model / Reference
- "Press Plus 3018 05-233018" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630136891 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED
- Unit of Use DI
- 06945630136894 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
SteriLance Disposable Safety Lancets are a cutting-edge, Class IIa medical device designed for sterile preparation of human tissues. These lancets feature advanced materials and manufacturing processes that ensure the highest level of sterility and safety.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6945630105BH | Class IIa | Active |
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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 (1)
- EUDAMED 40dea9a5-a9be-48ff-8db0-750afccac83d 61 fields · synced Jun 24, 2026