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Singapore HSA registration DE0505986

BMC F3 Full Face Mask

Singapore flagSingapore·CLASS B·BMC Medical Co., Ltd.·Registered July 14, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0505986
Registration Date
July 14, 2021
Retention Due Date
July 13, 2025
Product description
BMC F3 Full Face Mask channels airflow from ventilator systems non-invasively to the patients who suffer from obstructive sleep apnea (OSA) or 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 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, People's republic of china, CHINA
Registrant
Name
SG MEDICAL PTE LTD
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Importer
Name
SG MEDICAL PTE LTD
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model information
Model Name(s)
Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Full Face Mask Elbow Elbow Elbow Elbow
Model Identifier(s)
F3 (large) 10030397 with headgear, elbow V, NV1, NV2 and NV3 F3 (large) 10030400 with headgear, elbow NV2 F3 (large) 10030449 with headgear, elbow V F3 (large) 10030452 with headgear, elbow NV1 F3 (large) 10030455 with headgear, elbow NV3 F3 (large) 10030458 with headgear, elbow V, NV1 and NV2 F3(medium) 10030398 with headgear, elbow V, NV1, NV2 and NV3 F3(medium) 10030401 with headgear, elbow NV2 F3(medium) 10030450 with headgear, elbow V F3(medium) 10030453 with headgear, elbow NV1 F3(medium) 10030456 with headgear, elbow NV3 F3(medium)10030459 with headgear, elbow V, NV1 and NV2 F3(small) 10030402 with headgear, elbow NV2 F3(small) 10030451 with headgear, elbow V F3(small) 10030454 with headgear, elbow NV1 F3(small) 10030399 with headgear, elbow V, NV1, NV2 and NV3 F3(small) 10030457 with headgear, elbow NV3 F3(small) 10030460 with headgear, elbow V, NV1 and NV2 NV1 NV2 NV3 V
About this record

Access comprehensive regulatory information for BMC F3 Full Face Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505986 and owned by BMC Medical Co., Ltd.. The device was registered on July 14, 2021.

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