PaloDEx Group Oy
No description from the company. The catalog line you may see elsewhere is generated by us from the category and location, not a statement by the company.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Tuusula, Finland
- Categories
- 医療およびヘルスケア用品
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 4 official records from 3 official sources are on file. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Line of business as recorded in the state register: Manufacture of irradiation, electromedical and electrotherapeutic equipment (record type: registry-activity) [official record; status green] Line of business as recorded in the state register: Manufacture of irradiation, electromedical and electrotherapeutic equipment. Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-07-09. Finnish Patent and Registration Office (PRH)
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 10 medical devices: Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) (K241249, 2024-09-12), Orthopantomograph OP 3D LX (K230505, 2023-06-09), Orthopantomograph OP 3D (K180947, 2018-06-07) +7. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- Legally registered and still active (record type: registry-active-global) [official record; status green] Indicates the company is not dissolved or winding down. checked 2026-07-09. Finnish Patent and Registration Office (PRH)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)