Identity
- Trade Name
- Easy-Soft EUDAMED
- Device Name
- Disposable Blood Lancets EUDAMED
- Model / Reference
- Soft 28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630142137 EUDAMED16945630142120 EUDAMED
- Basic UDI-DI
- 6945630101B9 EUDAMED
- Unit of Use DI
- 06945630142130 EUDAMED06945630142123 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Easy-Soft by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6945630101B9 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 688b10ca-45a6-4dd4-a57b-0b47586ff8d8 61 fields · synced Jul 10, 2026
- EUDAMED ce2ecc2f-7f82-4630-a673-120b39a8ddd4 61 fields · synced May 19, 2026