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PaloDEx Group Oy

Finland·FI-MF-000004943

Last updated September 17, 2026

Information

Country: Finland
Address: 160, Nahkelantie , Tuusula, Finland
Website: dexis.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8005586120
PRRC Contact: Päivi Nousiainen
EUDAMED SRN: FI-MF-000004943
FDA FEI Number: 3005383085
DUNS Number: 459955188

Catalogue (142)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Idot Ip Set S2 X 6 Optime Type	901254-PTU	EUDAMEDFDA UDI	Class IIa	Active
Hygiene Bag Size 0 200 Pcs	900475-DEX	EUDAMEDFDA UDI	Class I	Active
Focus™	900986	EUDAMEDFDA UDI	Class IIb	Active
Scan Exam Hygiene Start Up Kit	900474	EUDAMED	Class I	Active
Temple Support Disposable Covers	900512-DEX	EUDAMEDFDA UDI	Class I	Active
DIGORA™ Optime	900682-PTU	EUDAMEDFDA UDI	Class IIa	Active
Scan eXam™	900467/901009-PTU	EUDAMEDFDA UDI	Class IIa	Active
Scan eXam™ One	900687-PTU	EUDAMED	Class IIa	Active
Occlusal 4c Kit Scan Exam	900801-DEX	EUDAMEDFDA UDI	Class IIa	Active
Disposable Plastic Bag Small Fmx New	9801872-SDX	EUDAMED	Class I	Active
Disposable Cover Roll	6801140-SDX	EUDAMEDFDA UDI	Class I	Active
Scanora 3dx	K130297	FDA 510(k)	Class II	Active
FS Ergo	K173646	FDA 510(k)	Class II	Active
Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)	K241249	FDA 510(k)	Class II	Active
Idot Ip Set S1 X 6 Optime Type	901253-PTU	EUDAMEDFDA UDI	Class IIa	Active
Bite Block Disposable Cover	900510-DEX	EUDAMEDFDA UDI	Class I	Active
Lip Support Disposable Cover	901011-DEX	EUDAMEDFDA UDI	Class I	Active
Optibag Size 2 200pcs	900185-PTU	EUDAMEDFDA UDI	Class I	Active
Std Ip Set S3 X 6 Scan Exam Type	901251-PTU	EUDAMEDFDA UDI	Class IIa	Active
Hygiene Start Up Kit Optime Size 2	203685	EUDAMED	Class I	Active
Std Ip Set S2 X 6 Scan Exam Type	901250-PTU	EUDAMEDFDA UDI	Class IIa	Active
Optibag Size 3 200pcs	900186-PTU	EUDAMEDFDA UDI	Class I	Active
Hygiene bag for Imaging Plate Systems SIZE 2 200 PCS	900477-DEX	EUDAMEDFDA UDI	Class I	Active
ORTHOPANTOMOGRAPH™ OP 3D Pro	901002	EUDAMEDFDA UDI	Class IIb	Active
Orthopantomograph™ Op 3d	901084	EUDAMEDFDA UDI	Class IIb	Active
Idot Ip Start Up Set	900609-PTU/900492	EUDAMEDFDA UDI	Class IIa	Active
Hygiene Bag Fl Size 2 200pcs	900372-DEX	EUDAMEDFDA UDI	Class I	Active
Std Ip Set S1 X 6 Optime Type	901245-PTU	EUDAMEDFDA UDI	Class IIa	Active
Std Ip Set 1x2. 2x2 Dt-1c	900769 / 900679-PTU	EUDAMEDFDA UDI	Class IIa	Active
Ear Holder Disposable Cover	900638-DEX	EUDAMEDFDA UDI	Class I	Active
Optibag Size 1 200pcs	900184-PTU	EUDAMEDFDA UDI	Class I	Active
Digora Bag Size 0 200 Pcs	901140	EUDAMEDFDA UDI	Class I	Active
ORTHOPANTOMOGRAPH™ OP 3D Pro	901004	EUDAMEDFDA UDI	Class IIb	Active
Orthopantomograph™ Op 3d	901085	EUDAMEDFDA UDI	Class IIb	Active
Hygiene Bag Fl Size 0 200 Pcs	900359-DEX	EUDAMEDFDA UDI	Class I	Active
Std Ip Start Up Set	900245/900491	EUDAMEDFDA UDI	Class IIa	Active
Carpus Holder	901074	EUDAMEDFDA UDI	Class I	Active
Comfort Occlusal Hygiene Bags for occlusal projection images, size 4C, 100 PCS	900606	EUDAMEDFDA UDI	Class I	Active
Disposable Plastic Bag Big Fmx New	9801871-SDX	EUDAMEDFDA UDI	Class I	Active
Idot Ip-Set 1x2. 2x2 Dt-1c	900768 / 900678-PTU	EUDAMEDFDA UDI	Class IIa	Active
Classic Bag Size 3 200 Pcs	900673-PTU	EUDAMEDFDA UDI	Class I	Active
Optibag Size 0 200pcs	900183-PTU	EUDAMEDFDA UDI	Class I	Active
ORTHOPANTOMOGRAPH™ OP 3D Pro	901005	EUDAMEDFDA UDI	Class IIb	Active
Classic Bag Size 2 200 Pcs	900672-PTU	EUDAMEDFDA UDI	Class I	Active
Bite Block Disposable Cover Roll	6801120-SDX	EUDAMEDFDA UDI	Class I	Active
Digora Bag Size 1 200 Pcs	901141	EUDAMEDFDA UDI	Class I	Active
Hygiene Bag Fl Size 1 200pcs	900371-DEX	EUDAMEDFDA UDI	Class I	Active
Bite block 10 pcs	901013	EUDAMEDFDA UDI	Class I	Active
Lip Support Disposable Cover	6801130-SDX	EUDAMEDFDA UDI	Class I	Active
Ear Holder Covers	208224	EUDAMEDFDA UDI	Class I	Active

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