Monitex Industrial Co., Ltd.
SAN-CHUNG CITY Taipei, TW
MONITEX INDUSTRIAL CO., LTD. appears in FDA device records in SAN-CHUNG CITY Taipei, TW. FDA records list 9 510(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 9 510(k) clearances for Monitex Industrial Co., Ltd. between 2005 and 2017. The busiest year on record is 2017, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161855 | LED Curing Light | EBZ | Substantially Equivalent | |
| K152192 | LED Curing Light | EBZ | Substantially Equivalent | |
| K153078 | LED Curing Light GT-2000 | EBZ | Substantially Equivalent | |
| K150205 | LED Curing Light | EBZ | Substantially Equivalent | |
| K133040 | LED CURING LIGHT | EBZ | Substantially Equivalent | |
| K091887 | LED CURING LIGHT, MODEL GT-1500 | EBZ | Substantially Equivalent | |
| K080035 | LED CURING LIGHT | EBZ | Substantially Equivalent | |
| K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 | EBZ | Substantially Equivalent | |
| K051203 | BLUELEX | EBZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003169405 | 3003169405 | MONITEX INDUSTRIAL CO., LTD. | 6F, 70 GUANG-FU RD., SEC 1,, SAN-CHUNG CITY Taipei 241-58 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain