AIRTEC2 LOW AIR LOSS THERAPY BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

AIR-N-GO

FDA 510(k)

FDA Class 1 ·Dental

VIVO

FDA 510(k)

FDA Class 2 ·Cardiovascular

Siemens Healthcare Diagnostics Inc.

FDA registration

BIT Analytical Instruments GmbH·5 products·🇩🇪 Germany

N Cuvettes Segments for BN II

FDA registration

Siemens Healthcare Diagnostics Products GmbH·5 products·🇩🇪 Germany

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS FOLATE II CALSET II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ANT TIBIA INTRAMEDÜLLER ÇİVİ TİTANYUM (ANT TIBIA INTRAMEDULLARY NAIL TITANIUM) 13 X 315 MMQ

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·1 device

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN INSTRUMENT

MTE spol. s r.o.

Importer

🇨🇿 Czechia

Oral Wound Dressing W/Drug And/Or Biologic

FDA classification

FDA Unclassified ·Oral Wound Dressing W/Drug And/Or Biologic

Oral Wound Dressing

FDA classification

FDA Unclassified ·Oral Wound Dressing

CERT3GLOBAL, UNIPESSOAL, LDA.

Authorized representative

🇵🇹 Portugal·13 Manufacturers·69 Devices

Genvinset® MTHFR multiplex

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Blackhills Diagnostic Resources S.L.U.·3 devices

Klic10 Blood Collection Accessories Set Z

Basic UDI-DI

EU MDR · Eu Md Class 2a ·1 device

MTS Systemtechnik s.r.o.

Authorized representative

🇨🇿 Czechia·2 Manufacturers·21 Devices

MATRIX 101 NEGATIVE GALVANIC GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

006-00-01-MDR

Certificate

MDR QMS·Mt Ortho·ITALCERT SRL

Plexus

FDA 510(k)

FDA Class 2 ·Cardiovascular