Quality System Certificate
>>

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 Certificate
>>1. CE Certificate

Product   Range

Certificate   Registr. No.

Notify   body

Digital   thermometers,

Nebulizers,   CPAP

HD 6010   4524 0001

>>2. Recognized by Japanese Government

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

>>3. FDA 510K
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

>>4. UL recognition: Available for some models depend on marketing demand.