NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

VIVOSORB SHEET, MODEL FS01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR, MODELS ND04, ND05

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

NEUROLAC NERVE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CN19/41136

Certificate

MDD Annex II (excluding section 4)·Counter Scientific Development (GZ) Limited·SGS Belgium NV·3 Basic UDI-DIs

M.2023.MDR.1012-1

Certificate

MDR QMS·Zrinski Solution GbR·UDEM Adriatic d.o.o.

M.2023.MDR1012-2

Certificate

MDR Technical Documentation·Zrinski Solution GbR·UDEM Adriatic d.o.o.

M.2023.MDR.1012

Certificate

MDR QMS·Zrinski Solution GbR·UDEM Adriatic d.o.o.

Krüger GbR

Importer

🇩🇪 Germany

Yyuka International GbR

Authorized representative

🇩🇪 Germany·1 Manufacturer·3 Devices

MXR Podoblock BV

Importer

🇳🇱 Netherlands

Yyuka International GbR

Importer

🇩🇪 Germany

Meter, Airway Pressure (Inspiratory Force)

FDA classification

FDA Class 2 ·Meter, Airway Pressure (Inspiratory Force)

Ballistocardiograph

FDA classification

FDA Class 2 ·Ballistocardiograph

Rheofilter XR

Basic UDI-DI

EU MDR · Eu Md Class 2b ·Asahi Kasei Medical Co., Ltd.·1 device

GeneXpert® Dx Systems

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Cepheid·3 devices

Tang, Höpner, Schneider GBR

Importer

🇩🇪 Germany

BValley GbR

System producer

🇩🇪 Germany