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Lancet
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XLE3022Model XLII, XL-B, XL-C, XL-D, XL-E
Identity
- Trade Name
- Lancet EUDAMEDxinle FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- Lancet EUDAMEDLANCET GRAY 30G X 2.2MM FDA UDI
- Model / Reference
- XLII, XL-B, XL-C, XL-D, XL-E EUDAMEDXLE3022 EUDAMEDXL-E 30G FDA UDI
- Description
- LANCET GRAY 30G X 2.2MM FDA UDI
Identifiers
- Catalog Number
- XLE3022 FDA UDI
- Primary DI / UDI-DI
- 06950383615909 EUDAMED06950383616357 FDA UDI
- Basic UDI-DI
- 69503836XL0201CANM EUDAMED
- Unit of Use DI
- 86950383615905 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Manual blood lancing device, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 30 Gauge FDA UDI
Lancet by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69503836XL0201CANM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 cfb17827-f6fb-425a-a00e-0a142dda0544 61 fields · synced Jun 19, 2026
- FDA UDI 099ce33a-0abf-4bed-a458-9250481721af 36 fields · synced May 30, 2026