# Biosystems S.A.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/biosystems-sa>
- Country: Spain (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: ES-MF-000000231

## Figures

- Devices: 361
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- 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
- EMDN [W01 Reagents](https://devicerts.com/categories/emdn/W01): 336 devices
- EMDN [W02 IVD instruments](https://devicerts.com/categories/emdn/W02): 18 devices
- EMDN [W05 IVD generic use consumables](https://devicerts.com/categories/emdn/W05): 4 devices

## Devices

The first 50 of 361, in the order of the canonical page, which lists them all.

- [alpha-AMYLASE - EPS](https://devicerts.com/devices/alpha-amylase-eps-11534) · ref 11534 · Class C · EUDAMED · status: Active
- [Glucose](https://devicerts.com/devices/glucose-11538) · ref 11538 · Class C · EUDAMED · status: Active
- [Glucose-Hexokinase](https://devicerts.com/devices/glucose-hexokinase-12756) · ref 12756 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE - EPS](https://devicerts.com/devices/alpha-amylase-eps-21534) · ref 21534 · Class C · EUDAMED · status: Active
- [Biochemistry Calibrator](https://devicerts.com/devices/biochemistry-calibrator-18011) · ref 18011 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE - DIRECT](https://devicerts.com/devices/alpha-amylase-direct-23550) · ref 23550 · Class C · EUDAMED · status: Active
- [Creatine Kinase-Mb (Ck-Mb)](https://devicerts.com/devices/creatine-kinase-mb-ck-mb-23792) · ref 23792 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE - DIRECT](https://devicerts.com/devices/alpha-amylase-direct-11550) · ref 11550 · Class C · EUDAMED · status: Active
- [Glucose](https://devicerts.com/devices/glucose-11504) · ref 11504 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE-PANCREATIC](https://devicerts.com/devices/alpha-amylase-pancreatic-12799) · ref 12799 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE - DIRECT](https://devicerts.com/devices/alpha-amylase-direct-11583) · ref 11583 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE - DIRECT](https://devicerts.com/devices/alpha-amylase-direct-21550) · ref 21550 · Class C · EUDAMED · status: Active
- [Creatine Kinase-Mb (Ck-Mb)](https://devicerts.com/devices/creatine-kinase-mb-ck-mb-11792) · ref 11792 · Class C · EUDAMED · status: Active
- [Glucose-Hexokinase](https://devicerts.com/devices/glucose-hexokinase-21656) · ref 21656 · Class C · EUDAMED · status: Active
- [Glucose](https://devicerts.com/devices/glucose-12503) · ref 12503 · Class C · EUDAMED · status: Active
- [Glucose](https://devicerts.com/devices/glucose-11803) · ref 11803 · Class C · EUDAMED · status: Active
- [Creatine Kinase-Mb (Ck-Mb)](https://devicerts.com/devices/creatine-kinase-mb-ck-mb-12566) · ref 12566 · Class C · EUDAMED · status: Active
- [Glucose](https://devicerts.com/devices/glucose-21503) · ref 21503 · Class C · EUDAMED · status: Active
- [Creatine Kinase-Mb (Ck-Mb) Standard](https://devicerts.com/devices/creatine-kinase-mb-ck-mb-standard-11824) · ref 11824 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE - EPS](https://devicerts.com/devices/alpha-amylase-eps-12535) · ref 12535 · Class C · EUDAMED · status: Active
- [Biochemistry Control Urine I/Ii](https://devicerts.com/devices/biochemistry-control-urine-i-ii-18054) · ref 18054 · Class C · EUDAMED · status: Active
- [Biochemistry Control Serum I/Ii](https://devicerts.com/devices/biochemistry-control-serum-i-ii-18009) · ref 18009 · Class C · EUDAMED · status: Active
- [Biochemistry Calibrator (Human)](https://devicerts.com/devices/biochemistry-calibrator-human-18044) · ref 18044 · Class C · EUDAMED · status: Active
- [Biochemistry Control Urine I/Ii](https://devicerts.com/devices/biochemistry-control-urine-i-ii-18066) · ref 18066 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE-PANCREATIC](https://devicerts.com/devices/alpha-amylase-pancreatic-11799) · ref 11799 · Class C · EUDAMED · status: Active
- [Glucose-Hexokinase](https://devicerts.com/devices/glucose-hexokinase-11656) · ref 11656 · Class C · EUDAMED · status: Active
- [Biochemistry Control Serum I/Ii](https://devicerts.com/devices/biochemistry-control-serum-i-ii-18005) · ref 18005 · Class C · EUDAMED · status: Active
- [Glucose](https://devicerts.com/devices/glucose-23503) · ref 23503 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE - DIRECT](https://devicerts.com/devices/alpha-amylase-direct-12550) · ref 12550 · Class C · EUDAMED · status: Active
- [Biochemistry Control Serum I/Ii](https://devicerts.com/devices/biochemistry-control-serum-i-ii-18010) · ref 18010 · Class C · EUDAMED · status: Active
- [Biochemistry Control Serum I/Ii (Human)](https://devicerts.com/devices/biochemistry-control-serum-i-ii-human-18042) · ref 18042 · Class C · EUDAMED · status: Active
- [Glucose-Hexokinase](https://devicerts.com/devices/glucose-hexokinase-23656) · ref 23656 · Class C · EUDAMED · status: Active
- [Creatine Kinase-Mb (Ck-Mb)](https://devicerts.com/devices/creatine-kinase-mb-ck-mb-21792) · ref 21792 · Class C · EUDAMED · status: Active
- [Glucose](https://devicerts.com/devices/glucose-11503) · ref 11503 · Class C · EUDAMED · status: Active
- [Biochemistry Control Serum I/Ii](https://devicerts.com/devices/biochemistry-control-serum-i-ii-18007) · ref 18007 · Class C · EUDAMED · status: Active
- [alpha-AMYLASE-PANCREATIC](https://devicerts.com/devices/alpha-amylase-pancreatic-21799) · ref 21799 · Class C · EUDAMED · status: Active
- [Biochemistry Control Serum I/Ii (Human)](https://devicerts.com/devices/biochemistry-control-serum-i-ii-human-18043) · ref 18043 · Class C · EUDAMED · status: Active
- [Ck-Mb Control Serum I/Ii](https://devicerts.com/devices/ck-mb-control-serum-i-ii-18061) · ref 18061 · Class C · EUDAMED · status: Active
- [Ck-Mb Control Serum I/Ii](https://devicerts.com/devices/ck-mb-control-serum-i-ii-18024) · ref 18024 · Class C · EUDAMED · status: Active
- [Bilirubin (Direct)](https://devicerts.com/devices/bilirubin-direct-11511) · ref 11511 · IVD General · EUDAMED · status: Active
- [Bilirubin (Total)](https://devicerts.com/devices/bilirubin-total-11544) · ref 11544 · IVD General · EUDAMED · status: Active
- [beta2-MICROGLOBULIN CONTROLS](https://devicerts.com/devices/beta2-microglobulin-controls-31592) · ref 31592 · IVD General · EUDAMED · status: Active
- [ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)](https://devicerts.com/devices/anti-neutrophil-cytoplasmic-antbodies-anca-formalin-50055) · ref 50055 · IVD General · EUDAMED · status: Active
- [Copper-Paesa](https://devicerts.com/devices/copper-paesa-11837) · ref 11837 · IVD General · EUDAMED · status: Active
- [Fitc/Evans (R)](https://devicerts.com/devices/fitc-evans-r-44836) · ref 44836 · IVD General · EUDAMED · status: Active
- [Gbma Positive Control](https://devicerts.com/devices/gbma-positive-control-44678) · ref 44678 · IVD General · EUDAMED · status: Active
- [Alkaline Washing Solution](https://devicerts.com/devices/alkaline-washing-solution-ac17205) · ref AC17205 · Class A · EUDAMED · status: Active
- [ANTI-Jo1 ANTIBODIES](https://devicerts.com/devices/anti-jo1-antibodies-44864) · ref 44864 · IVD General · EUDAMED · status: Active
- [Fecal Occult Blood (Fob) Standard](https://devicerts.com/devices/fecal-occult-blood-fob-standard-31326) · ref 31326 · IVD General · EUDAMED · status: Active
- [Anti-Endomysium Antibodies (Aea)](https://devicerts.com/devices/anti-endomysium-antibodies-aea-44710) · ref 44710 · IVD General · EUDAMED · status: Active

## EU certificates

- HX 1695779-1 · Quality management system · IVDR · notified body TÜV Rheinland LGA Products GmbH · issued 2026-10-06 · expires 2030-02-24 · status: supplemented

## Source and citation

- Cite as: Biosystems S.A. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/biosystems-sa (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/biosystems-sa.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/biosystems-sa
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.