OrbusNeich Medical (Shenzhen) Co.,Ltd

Manufacturer

🇨🇳 China·1058 Basic UDI-DIs·1058 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Baylis Medical Company Inc.

Manufacturer

🇨🇦 Canada·1 Importer

Puretone Ltd.

Manufacturer

LumaDent Inc

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·3 Devices

Delta Surgical Limited

Manufacturer

Oui Labs

Device

EU MDR · Eu Md Class 1 ·Oui Labs·On the market

VAGINAL DILATORS, REUSABLE

Device

EU MDR · Eu Md Class 1 ·Oui Labs·On the market

PELVIC FLOOR REHABILITATION DEVICES - OTHER

Device

EU MDR · Eu Md Class 1 ·Oui Labs·On the market

VAGINAL DILATORS, REUSABLE

Device

EU MDR · Eu Md Class 1 ·Oui Labs·On the market

VAGINAL DILATORS, REUSABLE

Device

EU MDR · Eu Md Class 1 ·Oui Labs·On the market

PELVIC FLOOR REHABILITATION DEVICES - OTHER

Device

EU MDR · Eu Md Class 1 ·Oui Labs·On the market

ANTIASTHMATIC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MONITORX LASERX THEOPHYLLINE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SODIUM AND POTASSIUM BY ION SELECTIVE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology