Taiwan Comfort Champ Manufacturing Co., Ltd.
Active in EUDAMEDTaiwanfrom SRN EUDAMED FDA SRN TW-MF-000037811 FEI 3016734135
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Caretechion GmbHDE
What Taiwan Comfort Champ Manufacturing Co., Ltd. makes
The company manufactures surgical face masks and medical face masks, which are personal protective equipment intended for use in clinical and healthcare settings.
These mask products fall under Class I and Class II medical device classifications and are listed in the European EUDAMED database and the U.S. FDA 510(k) registry; the manufacturer is based in Taiwan.
Catalogue
Surgical Face Mask Ref K212863
510(k) 510(k)Medical Face Mask Ref CMDII-01
CE MDR EUDAMED
Company details
- EUDAMED SRN
- TW-MF-000037811
- FDA FEI number
- 3016734135
- EUDAMED status
- Active
- EUDAMED registered name
- Taiwan Comfort Champ Manufacturing Co.,Ltd.
- EUDAMED abbreviated name
- Taiwan Comfort Champ
- Registered address
- No.55, Aly.51,Ln.50,Daren Rd., 330058, Taoyuan City, Taiwan
- Website
- taiwan-champ.com/
- [email protected]
- Phone
- +886 3 363 79 99
- PRRC contact
- Ula Ho
Frequently asked questions
How many devices does TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD. have in the registry?
The registry currently lists 2 devices for TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.'s devices?
Among its 2 most recently registered devices, TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD. in the registry?
The most recently registered devices listed for TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD. include Surgical Face Mask and Medical Face Mask.