Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.
Active in EUDAMEDPolandfrom SRN EUDAMED SRN PL-MF-000009264
- Devices
- 14
- Registrations
- EUDAMED
At a glance
EU certificates
3 of 3 in force.
Market reach
- European Union
- EUDAMED actor, 3 certificates
What Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. makes
The company manufactures over-the-counter gastrointestinal remedies, including effervescent tablets for indigestion relief (e.g., Salvit Gastricon), anti-flatulence preparations (e.g., ULGIX WZDĘCIA variants), and baby-specific flatulence relief (e.g., Ulgix Wzdęcia Baby). It also produces ultrasound gel (e.g., Żel do USG and ULGIX USG) for diagnostic imaging. The portfolio includes both single-ingredient and multi-symptom formulations targeting digestive discomfort.
The device portfolio spans Class I (low-risk items like ultrasound gel), Class IIb (moderate-risk gastrointestinal remedies), and Class III (higher-risk preparations). These products are registered in the EU’s eudamed database, adhering to EU Medical Device Regulation (MDR) requirements. The manufacturer is based in Poland and operates within the European regulatory framework for non-prescription and diagnostic aids.
Catalogue
Search and filter all 14 devicesCompany details
- EUDAMED SRN
- PL-MF-000009264
- SRN (system / procedure pack)
- PL-PR-000009265
- EU VAT number
- 895-17-29-489
- EUDAMED status
- Active
- EUDAMED registered name
- Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.
- EUDAMED abbreviated name
- PPF Hasco - Lek S.A.
- Registered address
- 242 E, Żmigrodzka, 51 - 131, Wrocław, Poland
- Website
- www.hasco-lek.pl
- facebook.com/GrupaHasco
- [email protected]
- PRRC contact
- Katarzyna Gałecka
EUDAMED certificates
3 certificates3 valid, 0 expiredMDR 3next expiry 28 Feb 2029
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. 1434 3 certificates
- 1434-MDR-003/2026 Active
Quality management system EU MDR
- Issued
- 12 Feb 2026
- Expires
- 11 Feb 2031
- 1434-MDR-004/2026 Active
Technical documentation EU MDR
- Issued
- 12 Feb 2026
- Expires
- 11 Feb 2031
- 1434-MDR-001/2024 Active
Quality management system EU MDR
- Issued
- 29 Feb 2024
- Expires
- 28 Feb 2029
- Valid from
- 1 Mar 2024
From the company website
We are a Polish manufacturer of leks, dietary supplements and preparations for the pharmacy and non-aptetic market. Our brands include: IBUM, DIH, Ulgix or NatureKaps.
Frequently asked questions
How many devices does Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. have in the registry?
The registry currently lists 14 devices for Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.'s devices?
Among its 14 most recently registered devices, Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. has devices listed in EUDAMED (14 devices).
What risk classes do Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.'s devices are Class I, Class IIb and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.?
EUDAMED lists 3 certificates for Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. (quality management system; technical documentation) under MDR. 3 are recorded with the status issued. The most recent was issued on 12 Feb 2026.
What are the newest devices from Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. in the registry?
The most recently registered devices listed for Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. include Kebene forte, Kebene extra, Simethicon 80 mg and Salvit Gastricon.