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Sterilance Adjustable Lancing Device with Ejector
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 02-1901-LDE 3Ref 02-2201——LDE 4
Identity
- Trade Name
- Sterilance Adjustable Lancing Device with Ejector EUDAMED
- Device Name
- Lancing Device EUDAMED
- Model / Reference
- 02-1901-LDE 3 EUDAMED02-2201——LDE 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945630116780 EUDAMED06945630116797 EUDAMED
- Basic UDI-DI
- 6945630102BB EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDNorthern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Adjustable Lancing Device with Ejector by Sterilance Medical (Suzhou) Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221970 | Class I | Active |
| 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 (3)
- EUDAMED b975efdc-c87d-4a3c-88b3-6a8b81b827de 61 fields · synced Aug 2, 2026
- EUDAMED ea44c072-4417-4efc-826f-fa7b814f02aa 61 fields · synced May 18, 2026
- FDA 510(k) K221970 1 fields · synced May 18, 2026