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xinle
EUDAMEDClass IIa (EU MDR)
Ref XLII2618Model XLII-2618Model XLII, XL-B, XL-C, XL-D, XL-E
Identity
- Trade Name
- xinle EUDAMEDLancet EUDAMED
- Device Name
- Lancet EUDAMED
- Model / Reference
- XLII-2618 EUDAMEDXLII2618 EUDAMEDXLII, XL-B, XL-C, XL-D, XL-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383615046 EUDAMED
- Basic UDI-DI
- B-06950383615046 EUDAMED69503836XL0201CANM EUDAMED
- Unit of Use DI
- 86950383615042 EUDAMED
- EMDN Code
- V010401 LANCETS WITH 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
Category: Blood lancet, single-use
xinle by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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-06950383615046 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06950383615046 | 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 9459563e-2219-4bc8-9db5-525cc3f48988 61 fields · synced Jul 11, 2026
- EUDAMED 9c49fe44-8e81-4888-9151-c29ef6878a65 61 fields · synced May 18, 2026