SANIT MAK L

Basic UDI-DI

EU MDR · Eu Md Class 1 ·S.A. PRODER·1 device

MEK-HEALTHCARE-CONSULTING UG

Importer

🇩🇪 Germany

Bizzy Diamond BV

Importer

🇳🇱 Netherlands·2 Manufacturers

No.2020-IVD/QS-008

Certificate

IVDD Annex IV (excluding sections 4, 6)·CTK Biotech Inc.·3EC International a.s.·1 Basic UDI-DI

MTS Systemtechnik s.r.o.

Authorized representative

🇨🇿 Czechia·2 Manufacturers·21 Devices

MATRIX 101 NEGATIVE GALVANIC GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MED MAKS, TRGOVINA IN STORITVE, D.O.O.

Importer

🇸🇮 Slovenia

WaterLase Laser Tips, MT4-6, Sapphire, 2PK

Basic UDI-DI

EU MDD · Eu Md Class 2a ·BIOLASE MG LLC·1 device

WaterLase Laser Tips, MT4-6, Sapphire, 5PK

Basic UDI-DI

EU MDD · Eu Md Class 2a ·BIOLASE MG LLC·1 device

Strap, Head, Gas Mask

FDA classification

FDA Class 1 ·Strap, Head, Gas Mask

Filter, Intravascular, Cardiovascular

FDA classification

FDA Class 2 ·Filter, Intravascular, Cardiovascular

11251-2017-CE-IND-NA-PS

Certificate

MDD Annex II Section 4·TTK Healthcare Limited (Ortho Division)·DNV Product Assurance AS·48 Basic UDI-DIs

MEK-HEALTHCARE-CONSULTING UG

Authorized representative

🇩🇪 Germany

Karl Meng/MKT MED

Authorized representative

🇩🇪 Germany

M.2023.MDR.1011

Certificate

MDR QA·MHK MEDİKAL TEKSTİL SAN VE TİC.LTD.ŞTİ·UDEM Adriatic d.o.o.

M.2023.MDR1011

Certificate

MDR QA·MHK MEDİKAL TEKSTİL SAN VE TİC.LTD.ŞTİ·UDEM Adriatic d.o.o.

CE-701506

Certificate

MDD Annex II (excluding section 4)·TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION·BSI Group The Netherlands B.V.·20 Basic UDI-DIs

434-MDD-406/2020

Certificate

MDD Annex II Section 4·TTK Healthcare Limited Heart Valve Division·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

Labware, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Labware, Assisted Reproduction, Exempt

MTS Medizintechnische Servicegesellschaft mbH

System producer

🇩🇪 Germany