URIT Medical Electronic Co., Ltd.
Guilin Guangxi, CN
URIT Medical Electronic Co., Ltd. appears in FDA device records in Guilin Guangxi, CN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for URIT Medical Electronic Co., Ltd. between 2009 and 2024. The busiest year on record is 2009, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | JIO | Substantially Equivalent | |
| K082811 | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS | JIO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010891909 | 3010891909 | URIT Medical Electronic Co., Ltd. | No. D-07, Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China, Guilin Guangxi 541004 CN | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- JHCAcid, Uric, Uricase (Oxygen Rate)
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JGYColorimetric Method, Triglycerides
- GGMControl, Hemoglobin
- JCBDetergent
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- CKDHydrazone Colorimetry, Alt/Sgpt
- CISHydrazone Colorimetry, Ast/Sgot
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LBRLdl & Vldl Precipitation, Hdl
- HJFMagnifier, Hand-Held, Low-Vision
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- JRERefractometer For Clinical Use
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- KSLSolution, Copper Sulfate For Specific Gravity Determinations
- MRRSystem, Test, Low Density, Lipoprotein
- LJXTest, Urine Leukocyte
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain