Elevator, Surgical, Dental

FDA classification

FDA Class 1 ·Elevator, Surgical, Dental

Test Reagents For Ethyl Alcohol

FDA classification

FDA Class 2 ·Test Reagents For Ethyl Alcohol

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

Mouthguard, Migraine/Tension Headache

FDA classification

FDA Unclassified ·Mouthguard, Migraine/Tension Headache

PulseLavage AB

Manufacturer

🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and Eurofins Electric & Electronics Finland Oy

Focus&Fusion Healthcare (Hangzhou) Co., Ltd

Manufacturer

🇨🇳 China·8 Basic UDI-DIs·87 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

QMT-Tech ab

System producer

🇸🇪 Sweden

Hettich Labinstrument

Importer

🇩🇰 Denmark·3 Manufacturers

Denture,restoration,orthodontic,anti-snoring,orthodontic

FDA UDI

Modern Dental Laboratory (DG) Co., Ltd.·06972677879989·

Innoventa Medica ApS

Manufacturer

🇩🇰 Denmark·3 Basic UDI-DIs·8 Devices·Intertek Medical Notified Body AB, Intertek Medical Notified Body AB, and Intertek Medical Notified Body AB

LSM-MED S.r.l.

Manufacturer

🇸🇲 San Marino·1 Basic UDI-DI·3 Devices·2 Importers·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

ANGIOLOGICA B.M. S.R.L.

Manufacturer

🇮🇹 Italy·3 Basic UDI-DIs·3 Devices·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

Shanghai HeartCare Medical Technology Corporation Limited

Manufacturer

🇨🇳 China·1 Basic UDI-DI·4 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

Cutera, Inc.

Manufacturer

🇺🇸 United States·17 Basic UDI-DIs·21 Devices·2 Importers·TUV NORD Polska Sp. z o.o and TÜV NORD CERT GmbH

Fimet Oy

Manufacturer

🇫🇮 Finland·8 Basic UDI-DIs·15 Devices·SGS FIMKO OY and SGS FIMKO OY

Taewoong Medical Co., Ltd.

Manufacturer

🇰🇷 South Korea·236 Basic UDI-DIs·236 Devices·17 Importers·SGS Belgium NV and SGS Belgium NV

Radiant Innovation Inc.

Manufacturer

🇹🇼 Taiwan·19 Basic UDI-DIs·47 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

Shenzhen Hawk Medical Instrument Co., Ltd.

Manufacturer

🇨🇳 China·15 Basic UDI-DIs·23 Devices·4 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Lombard Medical Limited

Manufacturer

499 Basic UDI-DIs·499 Devices·4 Importers·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

Eyenuk, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·Intertek Medical Notified Body AB and INTERTEK SEMKO AB