Republic of the Philippines
Department of Health FDA,
FOOD AND DRUG ADMINISTRATION (ous arora perme
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
CERTIFICATION
‘To Whom This May Concern:
‘This is to certify that the TRUCAL U is currently not required to be registered with
ice because the new Food and Drug Administration (FDA) Guidelines for the
registration of medical devices has not yet been issued.
This certification is issued upon the request of SYSMEX PHILIPPINES, INC. with
business address at 30" Floor MDC 100 Bldg. E. Rodriguez Jr. Avenue cor. Eastwood Avenue,
Bagumbayan, Quezon City for whatever legal purpose this may serve.
This certification is automatically cancelled or revoked upon the issuance of the
pertinent health products registration guidelines. This certificate cannot be used for advertising
purposes in whatever medium and neither can this certificate be construed as an endorsement
by the Center for Device Regulation, Radiation Health, and Research,
Done this 17" January 2018 at Alabang, Muntinlupa,
one Lo
"AN JUAN, MSe, MNSA, CESE
Director 1V
Center for Device Regulation, Radiation Health, and Research
ENGR. BAYANL
Not valid without FDA Seal
ORNo. : 0948537
Amount: PhP 24,280.00 (48 Products)
Date 12 January 2018,
LRD/CDRRHR_EXEMP-2018-1062
DTN; 20180112134030
‘mod
FDA.0253990