Gestenco International AB

Gestenco International AB

Address:FRIDKULLAGATAN 14,GOTEBORG Vastra Gotaland,SE

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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

Bracket, Plastic, Orthodontic (DYW) (2) Accessories, Retractor, Dental (EIF) (1)

Premarket Exempt

No Yes

Clear

Lip Retractor - 07333117000179 Catalog Number : LR-00-02

Device Class : 1

Duns Number: 354936098

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

Springtime - 07333117000216 Catalog Number : KITSP-55-55HKS

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Freddy - 07333117000223 Catalog Number : FCB-00-01HK

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

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