HANILMEDICAL CO.,LTD.

HANILMEDICAL CO.,LTD.

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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

Pad, Heating, Powered (IRT) (2) Massager, Therapeutic, Electric (ISA) (1)

Premarket Exempt

Yes

Clear

Ceramix mat M1 - 08800132500001 Catalog Number :

Device Class : 2

Duns Number: 687625082

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Ceramix mat S1 - 08800132500018 Catalog Number :

Device Class : 2

Duns Number: 687625082

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

HEALAX i Shoulder - 08800132500025 Catalog Number :

Device Class : 1

Duns Number: 687625082

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

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