Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Hospital Bed

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xiamen Neaq Imp.& Exp. Co., Ltd·1 device

Bedrail

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xiamen Neaq Imp.& Exp. Co., Ltd·1 device

OPTICAL FRAMES

Basic UDI-DI

EU MDR · Eu Md Class 1 ·WENZHOU KANGYE IMP.& EXP. CO., LTD·1 device

Bath Chair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xiamen Neaq Imp.& Exp. Co., Ltd·1 device

Rollator

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xiamen Neaq Imp.& Exp. Co., Ltd·1 device

UniCel® DxH 900 Coulter® Cellular Analysis System

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

UniCel® DxH 800 Coulter® Cellular Analysis System

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

UniCel® DxH 800 Coulter® Cellular Analysis System

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Simplesense Platform

FDA registration

Nanowear, Inc.·5 products·🇺🇸 United States

Zio® AT Patch

FDA registration

iRhythm Technologies, Inc.·5 products·🇺🇸 United States

Zio® AT Patch

FDA registration

IRHYTHM TECHNOLOGIES, INC.·5 products·🇺🇸 United States

Simplesense

FDA registration

Nanowear, Inc.·5 products·🇺🇸 United States

Hangzhou Singclean Medical Products Co., Ltd.

Manufacturer

🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Ice packs/Instant cold packs/Disposable ice pack/Instant ice packs/gel ice pack

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Hangzhou Weize Imp & Exp Co., Ltd.·3 devices

Applicator

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Hangzhou Weize Imp & Exp Co., Ltd.·1 device

Nasal irrigator

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NINGBO FUWELL IMP. & EXP. CO.,LTD.·6 devices

Mouth Guard

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xiamen Yizhou Imp. & Exp. Co., Ltd.·1 device

Sterilization Gusset Reel

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Anqing MedColor Imp. & Exp. Co.,Ltd·5 devices

Disposable Washing Glove

Basic UDI-DI

EU MDR · Eu Md Class 1 ·SUZHOU TEKTOP IMP & EXP CO.,LTD·1 device