METALS LEVEL 1

FDA UDI

UTAK LABORATORIES, INC.·B80001696000010·METALS LEVEL 1

LEAD LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800LEAD2WBFUMMC0·LEAD LEVEL 2

AnchorKnot Suture

FDA UDI

Baylis Médicale Cie Inc·00685447000440·Cartridge, White/Blue Co-braid, Polyethylene/Po...

AnchorKnot Suture

FDA UDI

Baylis Medical Technologies Inc·07540299000099·Cartridge, White/Blue Co-braid, Polyethylene/Po...

AnchorKnot Suture

FDA UDI

Baylis Medical Technologies Inc·07540299000037·Cut Length, White/Blue Co-braid, Polyethylene/P...

IMMUNOSUPPRESSANTS LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800IMMUN2WBFUNC0·IMMUNOSUPPRESSANTS LEVEL 2

METALS QC LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800METQC2WBPAML0·METALS QC LEVEL 2

LEAD LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800LEAD2WBVWDL0·LEAD LEVEL 2

LEAD LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800LEAD2WBFLGC0·LEAD LEVEL 2

HMSB LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800HMSB2WBFMAYO0·HMSB LEVEL 2

OXYCODONE PLUS LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800OXY2WBFQDCHANT0·OXYCODONE PLUS LEVEL 2

DAB Away Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Lumatas BioSystems Inc·1 device

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

PERSONAL CARE AIDS - OTHER

Device

EU MDR · Eu Md Class 1 ·Samela, Inc. d/b/a NorthShore Care Supply·On the market·32 countries

Titan Prime Universal HRP Polymer Detection Kit with DAB

Device

EU IVDR · Eu Ivd Class A ·Lumatas BioSystems Inc·On the market·32 countries

AUTO-VAC BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sportarredo LP1

FDA registration

SPORTARREDO GROUP S.C.·1 product·🇮🇹 Italy

P & E OPTICAL LTD.

FDA registration

P & E OPTICAL LTD.·1 product·🇨🇳 China

P & E OPTICAL LTD.

FDA registration

P & E OPTICAL LTD.·1 product·🇨🇳 China

OSCAR DE LA RENTA

FDA registration

EYE TOPIC OPTICAL CO.,LTD.·1 product·🇰🇷 South Korea