Biosystems S.A.
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000000231
Biosystems S.A. is a medical device manufacturer based in Spain, with 361 devices listed in EUDAMED and FDA 510(k) (EU IVD General, Class C and Class A; FDA Class II) as of 15 Nov 2026.
- Devices
- 361
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 358
- FDA 510(k) 3
- Device classes
- EU IVD General 290
- EU Class C 39
- EU Class A 29
- FDA Class II 3
- Top EMDN categories
- Identifiers
- EUDAMED SRN ES-MF-000000231
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Biosystems S.A. makes
The company produces diagnostic controls and reagents for laboratory testing, including beta2-microglobulin and fecal occult blood standards, as well as specific antibody controls like anti-Jo1 and anti-tTG IgG. It also manufactures solutions for sample preparation, such as alkaline washing solutions and reaction rotors for automated systems. Additional offerings include transferrin, haptoglobin, and copper-based analytical reagents for precision testing.
These products fall under Class A and Class II medical device classifications, with some listed as In Vitro Diagnostic (IVD) General devices. They are registered in the EU via eudamed and the FDA’s 510(k) pathway in the United States. The manufacturer is based in Spain.
Catalogue
Search and filter all 361 devicesShowing 1-50 of 361
Company details
- EUDAMED SRN
- ES-MF-000000231
- EU VAT number
- A08678823
- EUDAMED status
- Active
- EUDAMED registered name
- BIOSYSTEMS S.A.
- EUDAMED abbreviated name
- BIOSYSTEMS
- Registered address
- 30, COSTA BRAVA, 08030, BARCELONA, Spain
- Website
- www.biosystems.global
- llopez@biosystems.es
- Phone
- +34933110000
- PRRC contact
- Noelia Gil Martin
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 24 Feb 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HX 1695779-1 Active
Quality management system EU IVDR
- Issued
- 6 Oct 2026
- Expires
- 24 Feb 2030
- Reason
- Add device or group
From the company website
Biotech analytical solutions to improve health and well-being. Robust systems for Clinical, Veterinary, Food & Beverage and Environmental analysis.
Frequently asked questions
How many devices does BIOSYSTEMS S.A. have in the registry?
The registry currently lists 361 devices for BIOSYSTEMS S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOSYSTEMS S.A.'s devices?
Among its 50 most recently registered devices, BIOSYSTEMS S.A. has devices listed in EUDAMED (50 devices).
What risk classes do BIOSYSTEMS S.A.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for BIOSYSTEMS S.A.'s devices are IVDR Class A, IVDR Class C and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for BIOSYSTEMS S.A.?
EUDAMED lists 1 certificate for BIOSYSTEMS S.A. (quality management system) under IVDR. The most recent was issued on 6 Oct 2026.
What are the newest devices from BIOSYSTEMS S.A. in the registry?
The most recently registered devices listed for BIOSYSTEMS S.A. include alpha-AMYLASE - EPS, GLUCOSE, GLUCOSE-HEXOKINASE and BIOCHEMISTRY CALIBRATOR.