Identity
- Trade Name
- xinle EUDAMEDLancet EUDAMED
- Device Name
- Lancet EUDAMED
- Model / Reference
- XLIII-26 EUDAMEDXLIII26 EUDAMEDXLIII EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383615121 EUDAMED
- Basic UDI-DI
- B-06950383615121 EUDAMED69503836XL0202IMQ4 EUDAMED
- Unit of Use DI
- 86950383615127 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
xinle by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06950383615121 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06950383615121 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hebei Xinle Sci&Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000016692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 4b0e19da-490e-4cc1-b1b9-f3ea8ae9eddb 61 fields · synced Jul 20, 2026
- EUDAMED 567031a8-75ab-41f0-bd70-663545937752 61 fields · synced May 17, 2026