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Sign in to claim this brandTERRAGENE S.A.
Argentina·AR-MF-000047833
Last updated May 24, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Terragene S.A. manufacture?
Terragene S.A. specializes in sterilization verification devices, including biological and chemical/physical sterilization indicators. Their product line covers single-use chemical indicators like Chemdye™ and Tuttnauer®, as well as biological indicators such as Bionova® and BIOTRACE™, which monitor sterilization processes like steam and ethylene oxide. They also produce readers, like the VERISURE™ system, to analyze indicator results for validation in healthcare settings.
Where is Terragene S.A. based, and what regulatory databases list their devices?
Terragene S.A. is based in Argentina. Their devices are listed in key regulatory databases, including EUDAMED for European Union compliance, FDA’s 510(k) premarket notifications for U.S. regulatory submissions, and the FDA’s Unique Device Identifier (UDI) system to ensure traceability and identification of their products.
How are Terragene S.A.’s devices classified under medical device regulations?
Terragene S.A.’s devices fall under EU Class I and Class II classifications, depending on their intended use and risk level. Class I devices are generally low-risk, while Class II devices involve a higher level of risk and require additional regulatory scrutiny. These classifications align with international standards to ensure safety and efficacy in sterilization verification.
What is the purpose of Terragene S.A.’s biological and chemical sterilization indicators?
Terragene S.A.’s biological indicators (e.g., Bionova®, BIOTRACE™) verify the effectiveness of sterilization processes by detecting microbial survival, ensuring complete sterilization of medical instruments. Their chemical/physical indicators (e.g., Chemdye™, Tuttnauer®) provide real-time visual confirmation of exposure to sterilization conditions like heat or gas. Together, these indicators help healthcare providers validate sterilization cycles, reducing contamination risks.
Why are Terragene S.A.’s devices listed in multiple regulatory systems like FDA’s 510(k) and EUDAMED?
Listing in multiple regulatory systems ensures compliance with global medical device standards. The FDA’s 510(k) process confirms that a device is substantially equivalent to a predicate product in the U.S., while EUDAMED tracks devices under EU regulations. Inclusion in these systems demonstrates adherence to international safety and performance requirements, facilitating market access in both regions and supporting traceability for healthcare providers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Argentina
- Address
- Ruta Nacional N° 9, Km 280, Alvear, Argentina
- Website
- www.terragene.com
- —
- —
- [email protected]
- Phone
- +543415587007
- PRRC Contact
- Adrian Jesus Rovetto
- EUDAMED SRN
- AR-MF-000047833
- FDA FEI Number
- —
- DUNS Number
- 970856911
Catalogue (123)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chemdye® | BDA4/1 | FDA UDI | Class II | Active |
| Bionova® | Photon Auto-reader incubator (BPH) | FDA UDI | Class II | Active |
| Tuttnauer® | WTL198-0082 | FDA UDI | Class II | Active |
| Bionova® | KPCD224-2 | FDA UDI | Class II | Active |
| Bionova® | PCD225-2 | FDA UDI | Class II | Active |
| Cintape® | CT22 | FDA UDI | Class II | Active |
| Biotrace™ | 73400 | FDA UDI | Class II | Active |
| Bionova® | BT224 | FDA UDI | Class II | Active |
| Verisure™ | 73250 | FDA UDI | Class II | Active |
| Bionova® | KPCD220-2 | FDA UDI | Class II | Unknown |
| Bionova® | IC10/20FR | FDA UDI | Class II | Active |
| Tuttnauer® | WTL198-0067 | FDA UDI | Class II | Active |
| Verisure™ | 73180 | FDA UDI | Class II | Active |
| Tuttnauer® | PLZ198-0002 | FDA UDI | Class II | Active |
| Tuttnauer® | WTL198-0060 | FDA UDI | Class II | Active |
| Biotrace™ | 73135 | FDA UDI | Class II | Active |
| Tuttnauer® | WTL198-0072 | FDA UDI | Class II | Active |
| Bionova® | BT222 | FDA UDI | Class II | Active |
| Chemdye® | KBD8948X/1 | FDA UDI | Class II | Active |
| Bionova® | BT110 | FDA UDI | Class II | Active |
| Verisure™ | 73260 | FDA UDI | Class II | Active |
| Stryker | SLCD12 | FDA UDI | Class II | Active |
| Bionova® | MINIBIO | FDA UDI | Class II | Active |
| Tuttnauer® | WTL198-0072 | FDA UDI | Class II | Active |
| Bionova® | Hyper Auto-reader incubator (BHY) | FDA UDI | Class II | Active |
| Tuttnauer® | WTL198-0058 | FDA UDI | Class II | Active |
| Verisure™ | 73156 | FDA UDI | Class II | Active |
| Bionova® | KPCD222-2 | FDA UDI | Class II | Unknown |
| Bionova® | BT221 | FDA UDI | Class II | Active |
| Bionova® | BT225 | FDA UDI | Class II | Active |
| Biotrace™ | 73300 | FDA UDI | Class II | Active |
| Bionova® | BT224 | FDA UDI | Class II | Active |
| Cintape® | CT40 | FDA UDI | Class II | Active |
| Biotrace™ | 73110 | FDA UDI | Class II | Active |
| Bionova® | PCD224-C | FDA UDI | Class II | Active |
| Chemdye® | CD42 | FDA UDI | Class II | Active |
| Verisure™ | 73350 | FDA UDI | Class II | Active |
| Integron® | PCD26-C | FDA UDI | Class II | Active |
| Tuttnauer® | WTL198-0068 | FDA UDI | Class II | Active |
| Stryker | SCT40 | FDA UDI | Class II | Active |
| Bionova® | BT96 | FDA UDI | Class II | Active |
| Integron® | IT26-1YS | FDA UDI | Class II | Active |
| Chemdye® | CD29 | FDA UDI | Class II | Active |
| Biotrace™ | 73430 | FDA UDI | Class II | Active |
| Bionova® | KPCD225-C | FDA UDI | Class II | Active |
| Bionova® | KPCD224-2 | FDA UDI | Class II | Unknown |
| Bionova® | KPCD220-2 | FDA UDI | Class II | Active |
| Verisure™ | 73160 | FDA UDI | Class II | Active |
| Bionova® | BT110 | FDA UDI | Class II | Active |
| Bionova® | KPCD220-C | FDA UDI | Class II | Active |
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