Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REGENCY, SENSOLOG III, DIALOG II PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480225076·STAT PROFILE pHOx/BASIC/PLUS/L/C SENSOR

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480340816·Stat Profile pHOx Plus L Analyzer

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480347174·Remanufactured Stat Profile pHOx Plus L Analyzer

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480214971·STAT PROFILE pHOx/BASIC/PLUS/L/C REFERENCE LINE...

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480243278·STAT PROFILE pHOx/BASIC/PLUS/L/C FLUSH FIXTURE

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480346436·STAT PROFILE pHOx PLUS/C PROBE

GAMA GROUP a.s.

Manufacturer

🇨🇿 Czechia·164 Basic UDI-DIs·200 Devices·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., and ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.

Fin-ceramica faenza spa

Manufacturer

🇮🇹 Italy·71 Basic UDI-DIs·110 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer

🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Manufacturer

🇨🇳 China·334 Basic UDI-DIs·1887 Devices·29 Importers·SGS Belgium NV, SGS Belgium NV, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480248198·Stat Profile CCX Stat Profile pHOx/Basic/Plus/L...

ITH 1344699 1

Certificate

MDR QMS·Intersurgical SpA·TUV Rheinland Italia SRL

ITH 1344294 1

Certificate

MDR QMS·I.A.C.E.R. Srl·TUV Rheinland Italia SRL

ITH 1343248 1

Certificate

MDR QMS·Hydra srl·TUV Rheinland Italia SRL

HZ 2093717-1

Certificate

MDR QMS·J. MORITA MFG. CORP.·TÜV Rheinland LGA Products GmbH

ITH 2378440 1

Certificate

MDR QMS·DataRiver S.r.l.·TUV Rheinland Italia SRL