FDA.reportPublic FDA data

Hemoglobin Meter

Primary DI
06935740730723
Brand
Hemoglobin Meter
Company
Urit Medical Electronic Co., Ltd.
Model
PH-01A,1 Set/box
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GGMControl, Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGMControl, HemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740730723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740730723069357407307236935740730723

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin analyser IVD, laboratoryAn automated or semi-automated laboratory instrument intended to be used to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
653742429
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935740751568Fully-Automated Urine Chemistry AnalyzerDxU 1800c,1 unit2026-06-26
06935740751575Urine Chemistry StripsDxU 11FA, 100 Strips/tube"2026-06-26
06935740751582Urinalysis ControlDxU 11,1×8 mL DxU 11 NO.I 1×8 mL DxU 11 NO.II 1×8 2026-06-26
06935740751599Detergent Ready to UseDxU,1×5L2026-06-26
06935740751605Maintenance AgentDxU,1×1L2026-06-26
06935740751612SG ControlDxU,Level 1: 1×8mL, Level 2: 1×8mL, Level 3: 1×8mL2026-06-26
06935740751629Color ControlDxU,Red: 1×8mL, Yellow: 1×8mL, Green: 1×8mL2026-06-26
06935740751636Turbidity ControlDxU,Level 1: 1×8mL, Level 2: 1×8mL2026-06-26
06935740751643SG CalibratorDxU,2×8mL2026-06-26
06935740751650Turbidity CalibratorDxU,2×8mL2026-06-26
06935740751667Mutiple Control for SGDxU,8mL/vial, 4 vials/box2026-06-26
06935740751674Detergent ConcentratedDxU,1×500mL2026-06-26
06935740725705Blood Lipid AnalyzerPFS-30,1 Set/box2026-06-03
06935740725712Blood Lipid AnalyzerPFS-30A,1 Set/box2026-06-03
06935740730655Uric Acid MeterURIT-10,1 Set/box2026-06-03
06935740730679Uric Acid MeterPA-11,1 Set/box2026-06-03
06935740730716Hemoglobin MeterPH-01,1 Set/box2026-06-03
06935740751773Urine StripsUrineRS-11-MA2026-06-03
06935740751780URINE REAGENT STRIPSURITEST 11G2026-06-03
06935740751797URINE REAGENT STRIPSURITEST 13G2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740730716Hemoglobin MeterUrit Medical Electronic Co., Ltd.GGM2026-06-03
06935740751513Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2026-06-01
06935740751520Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2026-06-01
08718734962649CueSee® CO-OXEurotrol B.V.GGM2025-01-23
08718734962656CueSee® CO-OXEurotrol B.V.GGM2025-01-23
06935740726993Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-09-20
06935740733830Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733847Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733854Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2024-07-12
04048534001557DiaSpect Control Pack HBT1DiaSpect Medical GmbHGGM2022-12-20
04048534001564DiaSpect Control Pack HBT2DiaSpect Medical GmbHGGM2022-12-20
04048534001571DiaSpect Control Pack HBT3DiaSpect Medical GmbHGGM2022-12-20
04048534001588DiaSpect Control Pack HBT4DiaSpect Medical GmbHGGM2022-12-20
08718734961024CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961048CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961550CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961567CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961574CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961581CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961598CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961000CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961062CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961079CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961086CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961604CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962397CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961611CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962403CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961628CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961635CueSee® CO-OXEurotrol B.V.GGM2021-12-19