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DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

FDA 510(k)
FDA Class 2 ·Hematology

Atellica® CH Diazo Total Bilirubin (D_TBil)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Medipro, trzenje in raziskave, d.o.o.

Importer
🇸🇮 Slovenia·5 Manufacturers

2975-MED-2501401

Certificate
MDR QMS·DMS DENTAL MEDIKAL SANAYI VE TICARET ANONIM SIRKETI·SZUTEST Konformitätsbewertungsstelle GmbH

GMS MEDIKAL EGITIM ve INSAAT ANONIM SIRKETI

Importer
🇹🇷 Türkiye

S.A.L.F. S.p.A. Laboratorio Farmacologico

Manufacturer
🇮🇹 Italy·21 Basic UDI-DIs·202 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

MicroPort Orthopedics Inc.

Manufacturer
🇺🇸 United States·6 Basic UDI-DIs·75 Devices·3 Importers·ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

TatraMed Software s.r.o.

Manufacturer
🇸🇰 Slovakia·4 Basic UDI-DIs·6 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

GENSPEED Biotech

Manufacturer
🇦🇹 Austria·1 Basic UDI-DI·1 Device·QMD Services GmbH, QMD Services GmbH, QMD Services GmbH, and QMD Services GmbH

DEVINTEC SAGL

Manufacturer
🇨🇭 Switzerland·4 Basic UDI-DIs·16 Devices·5 Importers·BUREAU VERITAS ITALIA S.P.A., BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', and BUREAU VERITAS ITALIA S.P.A.

Elixir Medical Corporation

Manufacturer
🇺🇸 United States·2 Basic UDI-DIs·2 Devices·3 Importers·3EC International a.s., 3EC International a.s., and 3EC International a.s.

PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT

FDA 510(k)
FDA Class 2 ·Immunology

WOLF-Medizintechnik GmbH

Manufacturer
🇩🇪 Germany·8 Basic UDI-DIs·8 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

Medicap S.r.l

Manufacturer
🇮🇹 Italy·4 Basic UDI-DIs·5 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.

Manufacturer
🇨🇳 China·86 Basic UDI-DIs·107 Devices·5 Importers·TÜV Rheinland LGA Products GmbH, SGS Belgium NV, and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Shandong Lianfa Medical Plastic Products Co.,Ltd.

Manufacturer
🇨🇳 China·11 Basic UDI-DIs·90 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Andon Health Co., Ltd.

Manufacturer
🇨🇳 China·8 Basic UDI-DIs·11 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

EVOLUTIS

Manufacturer
🇫🇷 France·11 Basic UDI-DIs·109 Devices·ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL