Rolence Enterprise Inc.
Active in EUDAMEDTaiwanfrom SRN EUDAMED FDA SRN TW-MF-000024483
- Devices
- 17
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What Rolence Enterprise Inc. makes
Rolece Enterprise Inc. manufactures dental ultrasonic scalers, including models like the MS-30, PS-30, MS-50, and MS-1 series, designed for periodontal cleaning and plaque removal. Their portfolio also includes dental curing lights such as the 1800E, Q6-NLG, and other variants, used for polymerizing composite restorations. Additionally, they produce portable X-ray systems, including the Sensor RXS 1000 and XR-01, for intraoral imaging in dental practices.
The company’s devices are classified under EU regulations as Class I, Class II, Class IIa, and Class IIb, with some entries listed in the EUDAMED database and FDA’s 510(k) registry. Their products are intended for use in dental settings and comply with relevant regulatory frameworks in Taiwan and international markets.
Catalogue
Search and filter all 17 devicesCompany details
- EUDAMED SRN
- TW-MF-000024483
- DUNS number
- 656096658
- EU VAT number
- 05027112
- EUDAMED status
- Active
- EUDAMED registered name
- Rolence Enterprise Inc.
- Registered address
- 18-3, Pu Chung Rd., 32083, Taoyuan, Taiwan
- Website
- www.rolence.com.tw/
- [email protected]
- Phone
- +88634631999
- PRRC contact
- Ben Chang
FDA establishments
- Rolence Enterprise Co., Ltd. TW
Frequently asked questions
How many devices does ROLENCE ENTERPRISE INC. have in the registry?
The registry currently lists 17 devices for ROLENCE ENTERPRISE INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ROLENCE ENTERPRISE INC.'s devices?
Among its 17 most recently registered devices, ROLENCE ENTERPRISE INC. has devices listed in EUDAMED (16 devices), FDA 510(k) (1 device) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ROLENCE ENTERPRISE INC.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for ROLENCE ENTERPRISE INC.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from ROLENCE ENTERPRISE INC. in the registry?
The most recently registered devices listed for ROLENCE ENTERPRISE INC. include Ultrasonic Scaler MS-30, Ultrasonic Scaler PS-30, Dental Curing Light 1800E and Dental Curing Light.
Which FDA establishments are linked to ROLENCE ENTERPRISE INC.?
1 FDA establishment is linked to ROLENCE ENTERPRISE INC. in the registry; they are listed on the company page.