IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DBEST HCG PANEL TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Na-K-Ca-Cl Filling Solution

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Diamond Diagnostics Inc·1 device

Fluid Pack Eastlyte Na-K-Ca-pH

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Diamond Diagnostics Inc·1 device

Fluid Pack Ilyte NA/K/Ca/pH

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Diamond Diagnostics Inc·1 device

V.A.C.ULTA Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ST-302 INFRAREX

FDA 510(k)

FDA Class 2 ·Physical Medicine

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

SD-956 ULTRASOUND THERAPY

FDA 510(k)

FDA Class 2 ·Physical Medicine

IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

FDA 510(k)

FDA Class 2 ·Physical Medicine

SD-100 SKYEAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN INSTRUMENT

KCI Polymedics BV

Importer

🇧🇪 Belgium·1 Manufacturer

3M Deutschland GmbH (Medical)

Authorized representative

🇩🇪 Germany·3 Manufacturers

KCI Manufacturing Unlimited Company

Authorized representative

🇮🇪 Ireland·3 Manufacturers

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

FDA classification

FDA Class 1 ·Trocar, Tracheal, Laryngeal, Sinus, Reprocessed