FDA.reportPublic FDA data

Sterilized Eol Lancet Plus

Primary DI
08809262393408
Brand
Sterilized Eol Lancet Plus
Company
HLB CO.,LTD
Model
HCG LANCET 30G
Published
2025-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243533000Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare2025-01-13FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809262393408PrimaryGS10
08809262393934Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809262393408088092623934088809262393408
08809262393934088092623939348809262393934

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+82448629134qa2@hlbbio.co.kr

Regulatory Flags#

DUNS number
987587913
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809262391039Specimen Collection SwabFANAB012025-10-28
08809262391053Specimen Collection SwabFANTK012025-10-28
08809262391060Specimen Collection SwabFASPS022025-10-28
08809262391077Specimen Collection SwabFASPS102025-10-28
08809262391329Specimen Collection SwabFANAB012025-10-28
08809262391336Specimen Collection SwabFASPS022025-10-28
08809262391343Specimen Collection SwabFASPS022025-10-28
08809262391350Specimen Collection SwabFASPS022025-10-28
08809262391367Specimen Collection SwabFASPS022025-10-28
08809262391374Specimen Collection SwabFASPS102025-10-28
08809262391527Specimen Collection SwabFASPS102025-10-28
08809262391534Specimen Collection SwabFASPS102025-10-28
08809262392104Specimen Collection SwabFAPPP012025-10-28
08809262394030Specimen Collection SwabFANAB012025-10-28
08809262394047Specimen Collection SwabFANAB012025-10-28
08809262394061Specimen Collection SwabFASPS102025-10-28
08809262394078Specimen Collection SwabFASPS102025-10-28
08809262394085Specimen Collection SwabFASPS102025-10-28
08809262394092Specimen Collection SwabFASPS102025-10-28
08809262394115Specimen Collection SwabFASPS022025-10-28

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Primary DI, Brand, Company table
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00810011730748HuahongTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810011730755leraiseTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730762LinkSunTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810178887750Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00810178887767Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00816042013638FORAFORA CARE INC.FMK2026-06-23
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00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
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00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22