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Lancet
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XLE2118Model 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 GREEN 21G X 1.8MM FDA UDI
- Model / Reference
- XLII, XL-B, XL-C, XL-D, XL-E EUDAMEDXLE2118 EUDAMEDXL-E 21G FDA UDI
- Description
- LANCET GREEN 21G X 1.8MM FDA UDI
Identifiers
- Catalog Number
- XLE2118 FDA UDI
- Primary DI / UDI-DI
- 06950383615688 EUDAMED06950383616258 FDA UDI
- Basic UDI-DI
- 69503836XL0201CANM EUDAMED
- Unit of Use DI
- 86950383615684 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 — 21 Gauge FDA UDI
Category: Blood lancet, single-use
Lancet by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancet, single-use.
- Contact Activated Safety Lancet — NINGBO MEDSUN MEDICAL CO., LTD. · Class IIa
- TysonBio — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Safety Lancet (25G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- Safety Lancet (23G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- STERiLANCE — Sterilance Medical (Suzhou) Inc. · Class IIa
- Lite3 — Sterilance Medical (Suzhou) Inc. · Class IIa
- DropSafe Medlance Plus, safety lancets — HTL STREFA S A · Class II
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 4b8678ae-7225-49de-8d6b-11d2a17421b4 61 fields · synced Jun 18, 2026
- FDA UDI eefbb80c-e2aa-4f9e-bd91-cc83fcf6c7e2 36 fields · synced May 30, 2026