Transcendencias Comerciales S.L
Spain ES-MF-000006640 Last updated 23 Oct 2026
- Devices
- 11
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Hc-1 Ref Z-04
Hc-1 Classic Ref Z-01
Small Hydrokit Ref Z-10
Hc-2000 Classic Ref Z-02
Hydrokit with limiter Ref Z-17
8mm Gravity Hydrokit Ref Z-11
Segmented Hose / Large Hydrokit Ref Z-20
Hc-2000 Ref Z-05
Large Hydrokit Ref Z-09
EUDAMED certificates
Notified body 0051 1 certificate
- 059/MDR Amended
Quality management system EU MDR
- Issued
- 17 Jun 2026
- Expires
- 21 Nov 2027
- Reason
- Mnf data change
Related companies
Notified bodies
- Notified body 0051
What Transcendencias Comerciales S.L makes
Transcendencias Comerciales S.L manufactures hydrotherapy devices, including small and large hydrokits, gravity-fed systems with adjustable inflow sizes, and segmented hoses. Their portfolio includes models with built-in pressure limiters and classic versions of the HC-2000 series, designed for controlled water flow applications.
The company’s hydrotherapy devices are classified as Class IIa under EU regulations and are listed in the eudamed registry. The products are intended for use within the European market, adhering to EU Medical Device Regulation requirements.
Frequently asked questions
What types of medical devices does Transcendencias Comerciales S.L manufacture?
Transcendencias Comerciales S.L specializes in hydrotherapy devices. Their portfolio includes small and large hydrokits, gravity-fed systems with adjustable inflow sizes (such as 8mm and 10mm gravity hydrokits), segmented hoses, and models with built-in pressure limiters. These devices are designed for controlled water flow applications, typically used in therapeutic or rehabilitation settings.
Where is Transcendencias Comerciales S.L based?
The company is based in Spain (ES), as indicated by its country designation. This location aligns with its focus on supplying devices intended for the European market, including compliance with EU Medical Device Regulation requirements.
Which regulatory registries list Transcendencias Comerciales S.L’s devices?
The company’s devices are listed in the eudamed registry, which is the official EU database for medical devices. This registry ensures transparency and traceability of devices authorised under EU Medical Device Regulation (MDR).
How are Transcendencias Comerciales S.L’s hydrotherapy devices classified under EU regulations?
The company’s hydrotherapy devices fall under Class IIa classification according to EU Medical Device Regulation. This classification is determined based on the risk associated with the device’s intended use and design, with Class IIa representing a moderate-risk category requiring compliance with specific safety and performance requirements.
Information
- Country
- Spain
- Address
- 16, TROYA IBILBIDEA, ASTIGARRAGA, Spain
- Website
- www.transcomsl.com
- [email protected]
- Phone
- +34664492326
- PRRC contact
- Patricia Romero Bermudo
- EUDAMED SRN
- ES-MF-000006640
- FDA FEI number
- 3005346382