TAISSIS CONCEPT S.R.L.
Romania RO-MF-000001273 Last updated 17 Sep 2026
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- Devices
- 119
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Assorba Ref 100T8.2
Preops Ref 20.2KSUA
Preops Ref KH
Dr. Mayer Ref 100T16.10D
Dr. Mayer Ref 20CO2D
Dr. Protect Ref 50T8.10DP
Assorba Ref 75T8.2
Assorba Ref 100T16.10
Preops Ref 22KF
Preops Ref KSUC
Preops Ref KDB
Assorba Ref 75N4.25
Preops Ref KPK
Preops Ref 1KBP
Preops Ref 6.1KF
Assorba Ref 100N4.10
Bluetech Ref 3CO2DT
Preops Ref 3ACO2
Preops Ref K1CVC
Preops Ref KDRF
Preops Ref KCK
Dr. Mayer Ref 75N4.25D
Preops Ref 2KSUVA
Preops Ref KIMF
Preops Ref KKF
Preops Ref 3KTRA
Preops Ref KCVC
Preops Ref 2ARCO2
Assorba Ref 100N4.2
Preops Ref 6KF
Dr. Mayer Ref 50N4.10D
Preops Ref 2.1KPS
Assorba Ref 100T16.50O
Dr. Mayer Ref 3CO2D
Preops Ref K7CVC
Bluetech Ref 2CO2DT
Assorba Ref 100N4.5
Otialiv Ref NOS100
Pharsoin Ref 10KPGE
Preops Ref 2KF
Assorba Ref 200T8.5
Dr. Mayer Ref 50N4.100D
Preops Ref KDA
Preops Ref 4KSU
Assorba Ref 100T8.10
Assorba Ref 50N4.10
Calmogel Ref 1SGMG-CS
Preops Ref KSC
Preops Ref K6CVC
Preops Ref 18.2KSUA
Showing 1-50 of 119
About
At TAISSIS CONCEPT, the safety of medical devices is our priority. We offer ethylene oxide (EO) sterilization services according to ISO 11135: 2014, ensuring controlled, validated and fully traceable processes. Thus, we guarantee the quality and compliance required for the highest standards in the medical field.
What TAISSIS CONCEPT S.R.L. makes
Taisis Concept S.R.L. manufactures and supplies medical devices including Flamaderm (a topical treatment product), PHArtulle and Immerci TULLE (absorbent wound dressings), PREOPS (a pre-operative skin preparation solution), and Calmogel (a gel-based medical product). These products are designed for wound care, skin preparation, and topical application in clinical settings.
The company’s portfolio includes devices classified as Class I, Class IIa, and Class IIb under EU regulations, all registered in the EUDAMED database. Taisis Concept S.R.L. is based in Romania.
Frequently asked questions
What types of medical devices does TAISSIS CONCEPT S.R.L. manufacture and supply?
TAISSIS CONCEPT S.R.L. manufactures and supplies a range of medical devices primarily focused on wound care, skin preparation, and topical applications. Their portfolio includes products like Flamaderm (a topical treatment), PHArtulle and Immerci TULLE (absorbent wound dressings), PREOPS (a pre-operative skin preparation solution), and Calmogel (a gel-based medical product). These devices are designed for clinical use to address specific patient needs in these areas.
Where is TAISSIS CONCEPT S.R.L. based?
TAISSIS CONCEPT S.R.L. is based in Romania. The company’s location is relevant for regulatory compliance, as it operates under the EU’s medical device regulations, which govern its product development, manufacturing, and distribution processes.
Which regulatory registries list TAISSIS CONCEPT S.R.L.’s medical devices?
TAISSIS CONCEPT S.R.L.’s medical devices are listed in the EUDAMED database. This registry is the official European Union database for medical devices, where manufacturers declare information about their products, including classification, UDI (Unique Device Identification), and regulatory status, ensuring transparency and traceability within the EU market.
How are TAISSIS CONCEPT S.R.L.’s medical devices classified under EU regulations?
TAISSIS CONCEPT S.R.L.’s devices are classified as Class I, Class IIa, or Class IIb under EU medical device regulations. The classification determines the level of scrutiny and regulatory requirements a device must meet. For example, Class I devices generally pose minimal risk and require basic compliance measures, while Class IIa and IIb devices involve higher risks (e.g., wound dressings or pre-operative solutions) and require additional safety evaluations, such as clinical data or design controls, to ensure their safety and performance.
Information
- Country
- Romania
- Address
- 17, ION TICALOIU , CAMPULUNG, Romania
- Website
- www.taissis.ro
- [email protected]
- Phone
- +40248512830
- EUDAMED SRN
- RO-MF-000001273