Galmed Wytwornia Sprzetu Medycznego Katarzyna Meger
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
Galmed - Kami memproduksi peralatan medis berkualitas tinggi
GALMED adalah perusahaan keluarga. Pendiri Galmed adalah Marian Meger, saat ini usahanya dilanjutkan oleh putrinya, Katarzyna Meger. Perusahaan ini didirikan pada tahun 1980, dan sejak tahun 1985 kami telah memproduksi peralatan medis sekali pakai. Kami memulai produksi sebagai respons terhadap permintaan pasar, yang kehabisan peralatan impor. Sejak awal aktivitas kami, prioritas kami adalah kualitas dan keamanan produk. Kami memenuhi standar tinggi yang diberlakukan oleh Directive 93/42/EC, standar EN ISO 13485 serta standar yang diselaraskan. Kami memiliki sertifikat EC untuk semua produk.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Bydgoszcz, Poland
- Website
- https://galmed.com.pl
- Categories
- Perlengkapan Medis & Kesehatan
- Markets
- Polandia
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 1 official record from 1 official source is on file. 4 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
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-22. Domain registry record
- 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
- 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
- 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)
Check independently
Before a first order, ask for the legal entity's registration number and country, then check it in the official register.