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Lancet
EUDAMEDClass IIa (EU MDR)
Ref XLII2318Model XLII, XL-B, XL-C, XL-D, XL-EModel XLII-2318
Identity
- Trade Name
- Lancet EUDAMEDxinle EUDAMED
- Device Name
- Lancet EUDAMED
- Model / Reference
- XLII, XL-B, XL-C, XL-D, XL-E EUDAMEDXLII2318 EUDAMEDXLII-2318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383615039 EUDAMED
- Basic UDI-DI
- 69503836XL0201CANM EUDAMEDB-06950383615039 EUDAMED
- Unit of Use DI
- 86950383615035 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
Lancet by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — MDD, MDR — 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69503836XL0201CANM | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69503836XL0201CANM | 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 2a471404-934c-4196-8072-13d4f2a70b96 61 fields · synced Jul 9, 2026
- EUDAMED 3db68bb0-84a5-43ad-b0f9-0be426dba6be 61 fields · synced May 18, 2026