Unified Business No.

05027112

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 18-3, Ln. 231, Puzhong Rd., Zhongli Dist., Taoyuan City 32083, Taiwan (R.O.C.)↗
Taoyuan City (10,976) · Zhongli Dist. (1,194)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

1981-03-18

Paid-in capital

NT$ 65,400,000

Representative

Cheng Chih-cheng

Phone

03-4631999

Website

https://www.rolence.com.tw/index.asp

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Group subsidiary / corporate-held · Sen Mei Tou Tzu Co., Ltd.

North American market

FDA 510(k) clearance Health Canada medical device licence

Representative tenure

In office since at least 2013 (13+ years)

Certifications 19

• Medical device license (Class I) (1,430)Official registry Valid until 2016-04-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-06-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-07-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-07-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-06-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-06-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-12-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-10-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-08-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-08-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-05-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2010-09-21 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

North American market evidence 15

• FDA 510(k) clearance K202369 2021-09-15
  RXS 1000
• FDA 510(k) clearance K172928 2018-03-16
  Portable X-ray System
• FDA 510(k) clearance K001719 2000-10-10
  Q-LUX PLASMA 100 LIGHT CURE UNIT
• FDA 510(k) clearance K991865 1999-07-20
  Q-LITE 75 LIGHT CURE UNIT
• FDA 510(k) clearance K991863 1999-07-19
  CUTE-LITE I LIGHT CURE UNIT
• FDA 510(k) clearance K980792 1998-05-15
  CU-100A LIGHT CURE UNIT
• FDA 510(k) clearance K980793 1998-05-15
  Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
• FDA 510(k) clearance K960351 1996-04-15
  Q-LUX LIGHT CURE UNIT
• FDA 510(k) clearance K960364 1996-04-15
  CU-200 LIGHT CURE UNIT
• FDA 510(k) clearance K953628 1995-09-29
  PROPHY ANGLE
• FDA 510(k) clearance K952423 1995-06-22
  CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676
• FDA 510(k) clearance K942199 1994-06-02
  CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676
• FDA 510(k) clearance K942198 1994-05-27
  CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676
• FDA 510(k) clearance K924727 1993-06-17
  100 LIGHT CURE UNIT
• Health Canada medical device licence 124904

Similar companies 10

• FREE BIONICS TAIWAN INC. · Hsinchu City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• OMNIMATE ENTERPRISE CO., LTD. · Yilan County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• SOMNICS, INC. · Hsinchu County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• HMD BIOMEDICAL INC. · Hsinchu County Public company (unlisted) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• CARILEX MEDICAL, INC. · Taoyuan City Emerging stock (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, ISO 13485
• IXENSOR CO., LTD. · Taipei City Emerging stock (TPEx) NT$20–100M
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• MEDIC TRADE CO., LTD. · Taoyuan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• LAGIS ENTERPRISE CO., LTD. · Taichung City Listed (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• YI LIEN MEDICAL CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.

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