Appendix Rev.1 to 240230-2017-CE-BRA-NA-PS

Certificate

MDD Annex II (excluding section 4)·Medicone Projetos e Solucoes para a Industria e a Saude Ltda.·DNV Product Assurance AS·1 Basic UDI-DI

WT-128, WT-138, WT-148, WT-158, WT-168, WT-178, WT-188, WT-198, WT-298, WT-398, WT-129, WT-169,WT-139,WT-159

FDA registration

ICONBEAUTY (SHENZHEN) HOLDING LTD.·1 product·🇨🇳 China

AH-119, AH-121, AH-122, AH-123, AH-125, AH-126, AH-130, AH-132, AH-135

FDA registration

ICONBEAUTY (SHENZHEN) HOLDING LTD.·1 product·🇨🇳 China

Encompass/Unitexonline

FDA registration

YUNUS TEXTILE MILLS LIMITED·1 product·🇵🇰 Pakistan

Immuno Bactacol Febrile Antigens

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

Detector Rheumacol-Lex

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

CONTOUR NEXT ONE

FDA registration

PT PHC INDONESIA·1 product·🇮🇩 Indonesia

UNISIS CORP

FDA registration

UNISIS CORP·1 product·🇯🇵 Japan

UNISIS CORP

FDA registration

UNISIS CORP·1 product·🇯🇵 Japan

IMMUNOSTICS, INC.

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

Detector Rheumacol

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

hema-screen

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

Detector PREGNACOL 2000

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

IMMUNOSTICS, INC.

FDA registration

IMMUNOSTICS, INC.·11 products·🇺🇸 United States

UNISIS CORP

FDA registration

UNISIS CORP·1 product·🇯🇵 Japan

WING SHING OPTICAL MANUFACTURERS LIMITED

FDA registration

WING SHING OPTICAL MANUFACTURERS LIMITED·1 product·🇨🇳 China

Detector/Color-IM

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

IMMUNOSTICS, INC.

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

Detector Strepacol

FDA registration

IMMUNOSTICS, INC.·1 product·🇺🇸 United States

UNISIS CORP

FDA registration

UNISIS CORP·1 product·🇯🇵 Japan