Identity
- Trade Name
- MediSmart EUDAMED
- Device Name
- Lancing Device EUDAMEDDisposable Blood Lancets EUDAMED
- Model / Reference
- MS 204-00 EUDAMEDMS305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945630125133 EUDAMED16945630121545 EUDAMED
- Basic UDI-DI
- 6945630102BB EUDAMED6945630101B9 EUDAMED
- Unit of Use DI
- 06945630121548 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
MediSmart by Sterilance Medical (Suzhou) Inc. — Class I — 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 | 6945630102BB | Class I | 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 (2)
- EUDAMED 13d113b8-0b48-46ec-b61d-1d54a0e71ad9 61 fields · synced Jul 11, 2026
- EUDAMED 4a69be69-4408-4b8f-8aa5-8b22aec196a7 61 fields · synced May 18, 2026