HMD Biomedical, Inc.
Hsinchu County, TW
HMD BIOMEDICAL, INC. appears in FDA device records in Hsinchu County, TW. FDA records list 11 510(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 11 510(k) clearances for HMD Biomedical, Inc. between 2003 and 2022. The busiest year on record is 2012, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2008 | 1 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 | NBW | Substantially Equivalent | |
| K131173 | FIA Blood Glucose Monitoring System (G2) | NBW | Substantially Equivalent | |
| K121433 | GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS | LFR | Substantially Equivalent | |
| K113314 | PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | LFR | Substantially Equivalent | |
| K120064 | TEST, BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | |
| K113307 | GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM | LFR | Substantially Equivalent | |
| K072369 | EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K032985 | GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | |
| K023279 | GLUCOLEADER VALUE | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003902721 | 3003902721 | HMD BIOMEDICAL, INC. | No 181 Minsheng St, Xinpu Township, Hsinchu County Hsinchu(County) 305 TW | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- LFQAcid, Uric, Acid Reduction Of Ferric Ion
- JQPCalculator/Data Processing Module, For Clinical Use
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- FQLStocking, Medical Support (For General Medical Purposes)
- NBWSystem, Test, Blood Glucose, Over The Counter
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
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Data as of , FDA export datePage updated Source: openFDA, public domain