ChM sp. z o.o.

Listed in a source registry

ALIMS Serbia, register of medical-device manufacturers

What is established and what is not

No researcher review has been written for this company yet. 6 official records from 5 official sources are on file. 3 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. 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

• Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-22. Mail server of the company domain
• No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-22. OpenSanctions
• No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-22. OpenSanctions
• EU VAT number valid for cross-border trade (record type: vat-valid) [official record; status green] The number is registered and active: we asked the EU VIES service and it answered yes. An invalid VAT number is the first sign an invoice comes from the wrong company. checked 2026-10-03. Ministry of Finance VAT white list (Poland)
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 1 medical devices: ChM 4.5mm Cortical screws (K210490, 2021-10-05). 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)
• Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: LEWICKIE 3B, 16-061 LEWICKIE. The address the company itself gave the register, so post and inspectors reach it there. checked 2026-10-03. Ministry of Finance VAT white list (Poland)
• Line of business as recorded in the state register: PRODUKCJA URZĄDZEŃ, INSTRUMENTÓW ORAZ WYROBÓW MEDYCZNYCH, WŁĄCZAJĄC DENTYSTYCZNE (record type: registry-activity) [official record; status green] Line of business as recorded in the state register: PRODUKCJA URZĄDZEŃ, INSTRUMENTÓW ORAZ WYROBÓW MEDYCZNYCH, WŁĄCZAJĄC DENTYSTYCZNE. Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-10-03. REGON national business register (GUS, Poland)
• 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
• Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 387 public contracts on record, the latest awarded 2026-09-24. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-09-24. TED (Tenders Electronic Daily), EU public procurement award notices Burada ihalenin kazanılması başkasının yaptığı bir denetimi de taşır: AB ve AEA'da kamu alıcısı, dolandırıcılık, yolsuzluk veya kara para aklamadan hüküm giymiş istekliler ile kesinleşmiş kararla vergi veya sosyal güvenlik borcu saptananları elemek zorundadır. Bu denetim o ihale ve ihale tarihi için geçerliydi: şirketin bugünkü durumunu göstermez ve ihaleyi kazanmak sözleşmenin yerine getirildiğini göstermez. Directive 2014/24/EU, Article 57 (exclusion grounds)

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)

Check independently

• Sanctions and watchlists (OpenSanctions)