14 CompreFlex Arm

FDA UDI

SIGVARIS INC·00745129310943·Inelastic garment (or accessory) made of nylon ...

CompreFLEX

FDA UDI

SIGVARIS INC·00745129311797·Inelastic garment (or accessory) made of nylon ...

11 CompreFit

FDA UDI

SIGVARIS INC·00745129300661·Inelastic garment (or accessory) made of nylon ...

IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

Device

EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·On the market·32 countries

IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

BIOSTER, a.s.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Flídr medical s.r.o.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

KARDI AI Technologies s.r.o.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

ICZ.HEA a.s.

Manufacturer

🇨🇿 Czechia·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

BATIST Medical Productions s.r.o.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

COMPEX, spol. s r.o.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

VINAMET CZ s.r.o.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Spatz FGIA Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Rekovelle

Device

EU MDR · Eu Md Class 2a ·Ferring Pharmaceuticals A/S·On the market·27 countries

Beijing HumaDX Tech Co., Ltd.

Manufacturer

🇨🇳 China·1 Importer

ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

FDA 510(k)

FDA Class 2 ·Radiology

Abon Biopharm(Hangzhou) Co., Ltd

Manufacturer

🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, 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, GMED SAS, and GMED SAS

SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646

FDA 510(k)

FDA Class 2 ·Physical Medicine

PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.)

FDA 510(k)

FDA Class 1 ·General Hospital

FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER

FDA 510(k)

FDA Class 2 ·Radiology