COMPUTERIZED LABOR MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

RETROX

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HEM-AVERT PERIANAL STABILIZER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NUCLEUS-X PTV CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND

FDA 510(k)

FDA Class 2 ·Neurology

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

RESTLESS LEG DEVICE

FDA 510(k)

FDA Class 1 ·Physical Medicine

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

DIAMOND PROBE/PERIO 2000 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Non-Invasive Central Venous Manometer

FDA classification

FDA Class 2 ·Non-Invasive Central Venous Manometer

NSC ELECTROMEDICINA 2000 S.L.

Importer

🇪🇸 Spain

EUROIMMUN Medizinische Labordiagnostika AG

Importer

🇩🇪 Germany·1 Manufacturer

DLD Gesellschaft für Diagnostika und medizinische Geräte mbH

Importer

🇩🇪 Germany·1 Manufacturer

1839/MDD

Certificate

MDD Annex II (excluding section 4)·NSK Dental Italy S.r.l.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·2 Basic UDI-DIs

NSK Europe GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

VACUSERA® 2 ml ESR 4NC % 3,2 Sodium Citrate Blood Collection Tube

Basic UDI-DI

EU IVDD · Eu Ivd General ·DİSERA TIBBİ MALZEME LOJİSTİK SAN. VE TİC. A.Ş.·1 device