HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)

FDA 510(k)

FDA Class 2 ·Hematology

SURGICAL PATIENT WARMER, MODEL PW820 JHU

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS

FDA 510(k)

FDA Class 2 ·Anesthesiology

ZEST PETITE NASAL MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Enivo™

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kunze Indopharm.B.V.

Authorized representative

🇳🇱 Netherlands·1 Manufacturer

TNP/MDR/0018/3830/2024

Certificate

MDR QMS·FOLDIX MEDICAL INŻ. UWE WERNER PETRASCH·TUV NORD Polska Sp. z o.o

KNK Medical Sp. z o.o.

Importer

🇵🇱 Poland

DEVIPOL mgr inz. Zbigniew Matysiewicz

Importer

🇵🇱 Poland

Atomic Absorption, Arsenic

FDA classification

FDA Class 1 ·Atomic Absorption, Arsenic

Telescope, Laryngeal-Bronchial

FDA classification

FDA Class 2 ·Telescope, Laryngeal-Bronchial

Specific Protein Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

FOLDIX MEDICAL INŻ. UWE WERNER PETRASCH

Importer

🇵🇱 Poland

CROS/BI-CROS transmitter

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·21 devices

Bioprocen 22 R

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Álvarez Redondo, S.A.·1 device

KHANG BAO INTERNATIONAL KFT

Authorized representative

🇭🇺 Hungary·119 Manufacturers·1262 Devices

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices