Manufacturer

PaloDEx Group

FinlandLegal entities : PaloDEx Group Oy

First countries of placing on the market declared in EUDAMED : Finland

6 categories, 37 models including 29 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Equipment for digital endoral radiology	Z1103040102	DIGORA™ Optime DXR-6093/42 FOCUS™ OPENMOUNT™93/42 IDOT IP SET S0 X 6 OPTIME TYPE93/42 IDOT IP SET S0 X 6 SCAN EXAM TYPE93/42 IDOT IP SET S1 X 6 OPTIME TYPE93/42 24 others IDOT IP SET S1 X 6 SCAN EXAM TYPE93/42 IDOT IP SET S2 X 6 OPTIME TYPE93/42 IDOT IP SET S2 X 6 SCAN EXAM TYPE93/42 IDOT IP SET S3 X 6 OPTIME TYPE93/42 IDOT IP SET S3 X 6 SCAN EXAM TYPE93/42 IDOT IP-SET 1X2, 2X2 DT-193/42 IDOT IP-SET 1X2. 2X2 DT-1C93/42 OCCLUSAL 4C KIT SCAN EXAM93/42 Scan eXam™ One eXam 6-193/42 STD IP SET 1X2, 2X2 DT-193/42 STD IP SET 1X2. 2X2 DT-1C93/42 STD IP SET S0 X 6 OPTIME TYPE93/42 STD IP SET S0 X 6 SCAN EXAM TYPE93/42 STD IP SET S1 X 6 OPTIME TYPE93/42 STD IP SET S1 X 6 SCAN EXAM TYPE93/42 STD IP SET S2 X 6 OPTIME TYPE93/42 STD IP SET S2 X 6 SCAN EXAM TYPE93/42 STD IP SET S3 X 6 OPTIME TYPE93/42 STD IP SET S3 X 6 SCAN EXAM TYPE93/42 DIGORA™ Optime DXR-5093/42 (no longer marketed) IDOT IP START UP SET93/42 (no longer marketed) KAVO IDOT IP START UP SET93/42 (no longer marketed) Scan eXam™ eXam593/42 (no longer marketed) STD IP START UP SET93/42 (no longer marketed)	IIa, IIb 93/42	EUDAMED record Report an error
Equipment for conventional endoral radiology	Z1103040101	FOCUS™93/42 FOCUS™ Pro Focus / FNX-13 refs	IIb MDR, 93/42	EUDAMED record Report an error
Tomographs	Z11030507	ORTHOPANTOMOGRAPH™ OP 3D PCX-14 refs ORTHOPANTOMOGRAPH™ OP 3D Pro OP300-16 refs93/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
Instruments for digital endoral radiology - consumables	Z11030485	BITE BLOCK DISPOSABLE COVER ROLL3 refs	I MDR	EUDAMED record Report an error
Radiology instruments - hardware accessories	Z11030580	Bite block 10 pcs2 refs	I MDR	EUDAMED record Report an error
Instruments for extraoral dental radiology - medical device software No model still on the market	Z11030392	Cliniview™ 11 11.x93/42 (no longer marketed) Scanora 6 6.x93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error

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