25 results · 17ms · Sources: EU EUDAMED, US FDA

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ORA Method LED Gua Sha (GS-04)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

FDA Enforcement
Class I ·Ongoing·Jiangsu Well Biotech Co.,Ltd.·October 19, 2022

Taizhou Gongyou Glasses Co, Ltd

Manufacturer
🇨🇳 China

QUANZHOU ERA SANITARY PRODUCTS CO.,LTD.

Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices

Jiangmen New Era External Use Drug Co., Ltd

Manufacturer
🇨🇳 China·4 Basic UDI-DIs·4 Devices

Shanghai Gene Era Bio-Science Co., Ltd.

FDA registration
Shanghai Gene Era Bio-Science Co., Ltd.·8 products·🇨🇳 China

JIANGMEN NEW ERA EXTERNAL DRUG USE CO., LTD.

FDA registration
JIANGMEN NEW ERA EXTERNAL DRUG USE CO., LTD.·1 product·🇨🇳 China

ABSORBENT UNDERPADS - OTHER

Device
EU MDR · Eu Md Class 1 ·QUANZHOU ERA SANITARY PRODUCTS CO.,LTD.·On the market·32 countries

INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM

Device
EU MDR · Eu Md Class 1 ·QUANZHOU ERA SANITARY PRODUCTS CO.,LTD.·On the market·32 countries

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·On the market·32 countries

STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER

Device
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·On the market·32 countries

STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER

Device
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·On the market·32 countries

STERILISATION REELS - OTHER

Device
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·On the market·32 countries

Under Pads

Basic UDI-DI
EU MDR · Eu Md Class 1 ·QUANZHOU ERA SANITARY PRODUCTS CO.,LTD.·1 device

Adult diaper

Basic UDI-DI
EU MDR · Eu Md Class 1 ·QUANZHOU ERA SANITARY PRODUCTS CO.,LTD.·1 device

Skin Electrical Conductance Meters

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Qinhuangdao Huisianpu Medical Systems Inc·1 device

Cooling Gel Sheet

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·1 device

Autoclave Indicator Label

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·1 device

Autoclave Indicator Tape

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·1 device

Sterilization Packing Material (Roll)

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Jiangmen New Era External Use Drug Co., Ltd·1 device