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NANOSense
EUDAMEDClass IIa (EU MDR)
Ref 01-1928 SoftSense 28GRef 02-2401 OneStep
Identity
- Trade Name
- NANOSense EUDAMED
- Device Name
- Disposable Blood Lancets EUDAMEDLancing Device EUDAMED
- Model / Reference
- 01-1928 SoftSense 28G EUDAMED02-2401 OneStep EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630132800 EUDAMED06945630132797 EUDAMED
- Basic UDI-DI
- 6945630101B9 EUDAMED6945630102BB EUDAMED
- Unit of Use DI
- 06945630132803 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
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
NANOSense 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 |
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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 088fd6d2-40c6-4de7-a52c-b42eab26ac3f 61 fields · synced Jul 18, 2026
- EUDAMED 3c36d31c-e650-40cd-8d73-63b3462f827d 61 fields · synced May 19, 2026