Planmed Oy

Address:Sorvaajankatu 7,Helsinki Uusimaa,FI

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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

Full Field Digital, System, X-Ray, Mammographic (MUE) (1) Full Field Digital,System,X-Ray,Mammographic (MUE) (1) System, X-Ray, Mammographic (IZH) (1) X-Ray, Tomography, Computed, Dental (OAS) (1)

Premarket Exempt

Clear

Planmed - 06430035430024 Catalog Number :

Device Description : Planmed Nuance Excel is a mammographic x-ray unit intended for diagnosis of brea Planmed Nuance Excel is a mammographic x-ray unit intended for diagnosis of breast cancer.

Device Class : 2

Duns Number: 459718193

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

Planmed - 06430035430055 Catalog Number :

Device Description : Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of br Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer.

Device Class : 2

Duns Number: 459718193

Premarket Exempt : No

Product Code : IZH

Prescription Use : No

Device Count : 1

Planmed - 06430035430062 Catalog Number :

Device Description : Planmed Verity is a CBCT x-ray scanner for the diagnosis of extremities and the head.

Device Class : 2

Duns Number: 459718193

Premarket Exempt : No

Product Code : OAS

Prescription Use : No

Device Count : 1

Planmed - 06430035430079 Catalog Number :

Device Description : Planmed Clarity is a mammographic x-ray unit intended for diagnosis of breast cancer

Device Class : 2

Duns Number: 459718193

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

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