BYD Precision Manufacture Co., Ltd.

Address:No.3001 Baohe Road,Shenzhen Guangdong,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (2) Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance (QKR) (1) Respirator, Surgical (MSH) (1)

Premarket Exempt

No Yes

Clear

BYD CARE - 00850022724169 Catalog Number : FE2311

Device Description : BYD CARESingle-use Face MaskNon-sterileSoft & Easy to BreathBFE >= 98%PFE >= 98% BYD CARESingle-use Face MaskNon-sterileSoft & Easy to BreathBFE >= 98%PFE >= 98%Flammability: Class IASTM Level 3Flat MaskSpecifications:175mm×95mm / 6.89in.×3.74in10pcs/bag ×5bags

Device Class : 2

Duns Number: 545255648

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

BYD CARE - 00850022724176 Catalog Number : FE2311

Device Class : 2

Duns Number: 545255648

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

BYD CARE - 00860003624807 Catalog Number : FF1311

Device Description : Single-use Face MaskSoft & Easy to BreathUse as Surgical Mask

Device Class :

Duns Number: 545255648

Premarket Exempt : Yes

Product Code : QKR

Prescription Use : No

Device Count : 1

BYD CARE - 00860003645154 Catalog Number : DF1122

Device Description : N95 Health Care Particulate Respirator and Surgical Mask

Device Class : 2

Duns Number: 545255648

Premarket Exempt : Yes

Product Code : MSH

Prescription Use : No

Device Count : 1

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