HBI Health & Beauty International GmbH

Importer

🇩🇪 Germany

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

MediBeacon® Transdermal GFR Measurement System (TGFR)

Antisera, Hai, Reovirus 1-3

FDA classification

FDA Class 1 ·Antisera, Hai, Reovirus 1-3

Antisera, Hai, Adenovirus 1-33

FDA classification

FDA Class 1 ·Antisera, Hai, Adenovirus 1-33

Carrier, Amalgam, Operative

FDA classification

FDA Class 1 ·Carrier, Amalgam, Operative

Handpiece, Water-Powered

FDA classification

FDA Class 1 ·Handpiece, Water-Powered

Indicator, Alumina Fluorescent, Tlc

FDA classification

FDA Class 1 ·Indicator, Alumina Fluorescent, Tlc

Antisera, Hai, Parainfluenza Virus 1-4

FDA classification

FDA Class 1 ·Antisera, Hai, Parainfluenza Virus 1-4

Blade, Keratome, Reprocessed

FDA classification

FDA Class 1 ·Blade, Keratome, Reprocessed

Seating

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ki Mobility LLC·11 devices

Manual Wheelchair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ki Mobility LLC·18 devices

Antisera, Hai, Influenza Virus A, B, C

FDA classification

FDA Class 1 ·Antisera, Hai, Influenza Virus A, B, C

Glucose Kit (HK Method)

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Disposable Vaginal Speculums

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Changzhou Huankang Medical Device Co., Ltd.·1 device

DD 2068388-1

Certificate

MDD Annex V·INTCO MEDICAL (HK) CO., ltd·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

MED-RAS GmbH Regulatory Affairs Service

Authorized representative

🇩🇪 Germany·18 Manufacturers·235 Devices

HI (BTE)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·221 devices

HI (ITE)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·60 devices

HI (BTE)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·126 devices