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Lancet
EUDAMEDClass IIa (EU MDR)
Ref XLII2122Model XLII, XL-B, XL-C, XL-D, XL-EModel XLII-2122
Identity
- Trade Name
- Lancet EUDAMEDxinle EUDAMED
- Device Name
- Lancet EUDAMED
- Model / Reference
- XLII, XL-B, XL-C, XL-D, XL-E EUDAMEDXLII2122 EUDAMEDXLII-2122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383615015 EUDAMED
- Basic UDI-DI
- 69503836XL0201CANM EUDAMEDB-06950383615015 EUDAMED
- Unit of Use DI
- 86950383615011 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 0d7ce1f5-e3ac-407e-b025-200e37148f8c 61 fields · synced Jul 9, 2026
- EUDAMED 393567df-0b8d-44c7-b175-224476953745 61 fields · synced May 17, 2026