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Singapore HSA registration DE0505076

BMC Medical F2 NV Full Face Masks

Singapore flagSingapore·CLASS B·BMC Medical Co., Ltd.·Registered October 27, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0505076
Registration Date
October 27, 2020
Change Notification Approval Date
April 22, 2022
Retention Due Date
October 26, 2025
Product description
The mask is intended to be used with active-exhaust-valve ventilator systems, to provide ventilatory assistance to patients with respiratory insufficiency and respiratory failure. • The mask is to be used by adult patients (> 30 kg) requiring non-life-support ventilator assistance. • The mask is intended for single-patient use, for a maximum of seven days, in the hospital or clinical environment.
Product Owner
Name
BMC Medical Co., Ltd.
Short Name
BMC Medical Co., Ltd.
Address
Room 110 Tower A Fengyu Building, No.115 Fucheng Road Haidian, 100036 Beijing, CHINA
Registrant
Name
MEDWORX INTERNATIONAL PRIVATE LIMITED
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Importer
Name
MEDWORX INTERNATIONAL PRIVATE LIMITED
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Model information
Model Name(s)
F2 NV Full Face Mask F2 NV Full Face Mask F2 NV Full Face Mask F2 NV Full Face Mask F2 NV Full Face Mask F2 NV Full Face Mask
Model Identifier(s)
F2 NV1 (L) F2 NV1 (M F2 NV1 (S) F2 NV2 (L) F2 NV2 (M) F2 NV2 (S)
About this record

Access comprehensive regulatory information for BMC Medical F2 NV Full Face Masks in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505076 and owned by BMC Medical Co., Ltd.. The device was registered on October 27, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B