Acid-Sphingomyelinase (Asm) Newborn Screening Test System

FDA classification

FDA Class 2 ·Acid-Sphingomyelinase (Asm) Newborn Screening Test System

Dam Medical BV

Importer

🇳🇱 Netherlands

DSSM AG

Authorized representative

🇱🇮 Liechtenstein·1 Manufacturer

CC Chemie GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

Clamp, Rubber Dam

FDA classification

FDA Class 1 ·Clamp, Rubber Dam

Frame, Rubber Dam

FDA classification

FDA Class 1 ·Frame, Rubber Dam

MED 31220

Certificate

MDD Annex II (excluding section 4)·DBM SRL·KIWA CERMET ITALIA S.P.A.·3 Basic UDI-DIs

DD60149886

Certificate

MDD Annex V·Dam S.r.l.·TUV Rheinland Italia SRL·1 Basic UDI-DI

ANA Screen IgG ELISA

FDA UDI

DRG International Inc·00840239027733·The ANA Screen ELISA test system is a qualitati...

ANA Screen IgG ELISA

FDA UDI

DRG Instruments Gesellschaft mit beschränkter Haftung·04048474027730·The ANA Screen ELISA test system is a qualitati...

Bioclear Evolve Posterior Kit

FDA UDI

Bioclear Matrix Systems·D9498270513·Convenience kit of Bioclear products used in po...

Bioclear Evolve Posterior Kit

FDA UDI

Bioclear Matrix Systems·D9498270512·Convenience kit of Bioclear products used in po...

Select Bioclear Evolve Posterior Kit

FDA UDI

Bioclear Matrix Systems·D9498271112·Convenience kit of Bioclear products used in po...

Engelbrecht Medizin- und Labortechnik GmbH

Importer

🇩🇪 Germany·3 Manufacturers

Oral Lubricant

FDA classification

FDA Class 1 ·Oral Lubricant

Forceps, Rubber Dam Clamp

FDA classification

FDA Class 1 ·Forceps, Rubber Dam Clamp

DSP BIOMEDICAL EUROPA

Authorized representative

🇵🇹 Portugal·1 Manufacturer

ELISA ANA Screen Smart Kit Test System

FDA UDI

ZEUS SCIENTIFIC, INC.·00845533000147·The ZEUS ELISA ANA Screen Test System is a qual...

ELISA ANA Screen Test System

FDA UDI

ZEUS SCIENTIFIC, INC.·00845533000130·The ZEUS ELISA ANA Screen Test System is a qual...

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device