HRS Co., Ltd.

Address:7, Chupalsandan 2-gil,Pyongtaek Gyeonggi,KR

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Filters

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

Material, Impression (ELW) (7)

Premarket Exempt

Clear

Sildent Light Body - 18809746990014 Catalog Number :

Device Class :

Duns Number: 688000574

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 5

Sildent Regular Body - 18809746990021 Catalog Number :

Device Class : 2

Duns Number: 688000574

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 5

Sildent Heavy Body - 18809746990038 Catalog Number :

Device Class : 2

Duns Number: 688000574

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 5

Sildent Putty - 18809746990045 Catalog Number :

Device Class : 2

Duns Number: 688000574

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Sildent Fast Light Body - 18809746990052 Catalog Number :

Device Class : 2

Duns Number: 688000574

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 5

Sildent Fast Heavy Body - 18809746990069 Catalog Number :

Device Class : 2

Duns Number: 688000574

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 5

Sildent Bite - 18809746990076 Catalog Number :

Device Class : 2

Duns Number: 688000574

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 5

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