Identity
- Trade Name
- Boots EUDAMED
- Device Name
- Lancing Device EUDAMEDDisposable Blood Lancets EUDAMED
- Model / Reference
- LDE4 EUDAMEDSoft 28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945630136085 EUDAMED16945630135955 EUDAMED16945630135948 EUDAMED
- Basic UDI-DI
- 6945630102BB EUDAMED6945630101B9 EUDAMED
- Unit of Use DI
- 06945630135958 EUDAMED06945630135941 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa 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
Boots 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 (3)
- EUDAMED 5e4a6a68-db24-47fe-8f25-a379b8dafa30 61 fields · synced Jul 13, 2026
- EUDAMED 0d1d2f77-14fd-40f4-a49d-67ff1a1b5f79 61 fields · synced May 17, 2026
- EUDAMED 97bff5d8-2148-440d-9863-4504a39222d5 61 fields · synced May 19, 2026