Identity
- Trade Name
- Sterilized Eol Lancet Plus FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Model / Reference
- HCG LANCET 30G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809262393255 FDA UDI
- 510(k) Number
- K243533 FDA UDI
- FDA Product Code
- FMK FDA UDIQRK FDA UDI
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Category: Blood lancet, single-useManual blood lancing device, single-use
Sterilized Eol Lancet Plus by Hlb Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual blood lancing device, single-use.
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Cleared under the same submission
K243533 also covers:
- Sterilized Eol Auto Lancet — HLB CO., LTD
- Sterilized Eol Auto Lancet — HLB CO., LTD
- Sterilized Eol Auto Lancet — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- Sterilized Eol Lancet Plus — HLB CO., LTD
- SureComfort Safety Lancet — HLB CO., LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hlb Co., Ltd
Sources (1)
- FDA UDI ba4e823f-49b2-4f87-aa4a-85d1849e673e 34 fields · synced Jun 1, 2026