Terragene S.A.
Active in EUDAMEDArgentinafrom SRN EUDAMED SRN AR-MF-000047833
- Devices
- 185
- Registrations
- EUDAMED
- FDA recalls
- 33 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
What Terragene S.A. makes
Terragene S.A. manufactures biological and chemical/physical sterilization indicators, including single-use dyes and multi-parameter readers designed to verify sterilization processes. Their product line includes chemical indicators like Chemdye™ and Tuttnauer®, as well as biological indicators such as Bionova® and BIOTRACE™, which monitor steam, ethylene oxide, and other sterilization methods. The company also produces readers, including the VERISURE™ system, to interpret indicator results for validation purposes.
The company’s devices are classified under EU Class I and Class II regulations, with listings in the EUDAMED database, FDA’s 510(k) premarket notifications, and the FDA’s Unique Device Identifier (UDI) system. Their products are intended for use in healthcare settings to ensure sterilization efficacy, adhering to international regulatory standards for medical device compliance.
Catalogue
Search and filter all 185 devicesShowing 1-50 of 185
Company details
- EUDAMED SRN
- AR-MF-000047833
- DUNS number
- 970856911
- EUDAMED status
- Active
- EUDAMED registered name
- Terragene S.A.
- Registered address
- Ruta Nacional N° 9, Km 280, 2130, Alvear, Argentina
- Website
- www.terragene.com
- Phone
- +543415587007
- PRRC contact
- Adrian Jesus Rovetto
FDA recalls
FDA recall records list 3 recalls initiated by TERRAGENE S.A., the earliest on 2023-12-07 and the most recent on 2025-01-15. By recorded status: 3 ongoing. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 2
- 2024 0
- 2025 1
- 2026 0
2025
- 15 Jan 2025 Z-1248-2025 Class II Ongoing Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
2023
- 7 Dec 2023 Z-0836-2024 Class II Ongoing Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
- 7 Dec 2023 Z-0837-2024 Class II Ongoing Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Frequently asked questions
How many devices does TERRAGENE S.A. have in the registry?
The registry currently lists 185 devices for TERRAGENE S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list TERRAGENE S.A.'s devices?
Among its 50 most recently registered devices, TERRAGENE S.A. has devices listed in EUDAMED (41 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do TERRAGENE S.A.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for TERRAGENE S.A.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for TERRAGENE S.A.?
FDA recall records list 3 recalls initiated by TERRAGENE S.A., the most recent initiated on 15 Jan 2025. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from TERRAGENE S.A. in the registry?
The most recently registered devices listed for TERRAGENE S.A. include Integron™ IT28, Chemdye™ PCD-A-3.5Y, Integron™ IT31 and Chemdye™ PCD-A-3.5BD.