ISO 9001: 2008 | Certificate Registr. No.: 01 100 1532437 |
ISO 13485: 2012 | Certificate Registr. No.: SX 60106219 0001 |
CMDCAS 13485: 2003 | Certificate Registr. No.: 74 500 4788 |
Product Range | Certificate Registr. No. | Notify body |
Digital thermometers, Nebulizers, CPAP | HD 6010 4524 0001 |
|
Accreditation Certificate of foreign medical device manufacturer | Certificate Registr. No.: BG10500279 |
指定外國製造事業者指定書 | Certificate Registr. No.: 08CN07 |
| FDA Registration Number: 9616843 FDA Operator Number: 9036509 | |||||
Product range | 510k # | Device Listing # | Product Code | Regulation Number | Regulatory Class |
Compressor Nebulizer (CN-01,02,03) | K031413 | E565215 | BTI, CAF(neb bottle) | 868.6250 | II (two) |
Ultrasonic Nebulizer (NB) | K002831 | E565217 | CAF | 868.5630 | II |
Digital Thermometer (MT) | K041516 | E565216 | FLL | 880.2910 | II |
CPAP | K102625 | D125318 | BZD(CP-03), BTT(HH-02) | 21 CFR 868.5905 | II |
Suction Pump | K102626 | D109581 | JCX | 21 CFR 878.4780 | II |
Infrared Ear Thermometer (IR-04MT) | K102934 | D115001 | FLL | 21 CFR 880.2910 | II |
Massager | exempt | E332471 | ISA | I | |
Mask for nebulizer | exempt | D149797 | BSJ | I | |
