2195-MED-203601-D03

Certificate

MDD Annex II Section 4·LİNACOL MEDİKAL A.Ş.·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

SN-ROTH 0.022”（U）

Certificate

MDD Annex V·Beijing Smart Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

IT288297

Certificate

MDD Annex II (excluding section 4)·CUREXO, INC.·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI

CE 633491

Certificate

MDD Annex II Section 4·Nagor Limited·BSI Group The Netherlands B.V.·1 Basic UDI-DI

Remedee wristband F

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Remedee Labs SA·2 devices

Diamond Orthopedic

FDA UDI

DIAMOND ORTHOPEDIC, LLC·B551DMDKIT150T10S0·Single-Use Instrumentation Kit, T10

Diamond Orthopedic

FDA UDI

DIAMOND ORTHOPEDIC, LLC·B551DMDKIT125T05S0·Single-Use Instrumentation Kit, T05

Diamond Orthopedic

FDA UDI

DIAMOND ORTHOPEDIC, LLC·B551DMDKIT150T15S0·Single-Use Instrumentation Kit, T15

Kappa, Peroxidase, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Kappa, Peroxidase, Antigen, Antiserum, Control

Sulfophosphovanillin, Colorimetry, Total Lipids

FDA classification

FDA Class 1 ·Sulfophosphovanillin, Colorimetry, Total Lipids

Spirit Healthcare s.r.o.

Authorized representative

🇨🇿 Czechia·1 Manufacturer

Grambly GmbH

Authorized representative

🇩🇪 Germany·2 Manufacturers·1 Device

DEVINTEC HEALTH S.L.

Authorized representative

🇪🇸 Spain·1 Manufacturer·16 Devices

CEISO

Authorized representative

🇫🇷 France

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Copan Italia S.P.A.

System producer

🇮🇹 Italy

TendoNova Ocelot

FDA UDI

Tendonova Corporation·00860009899865·TendoNova Disposable Unit 60mm Kit-Single

VID81-

Basic UDI-DI

EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

FDA classification

FDA Not Classified ·Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

Igg (Fd Fragment Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Igg (Fd Fragment Specific), Antigen, Antiserum, Control