CLASSYS Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000010116
Part of Classys
CLASSYS Inc. is a medical device manufacturer based in South Korea, with 108 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb, I and IIa) as of 13 Nov 2026.
- Devices
- 108
- Registrations
- EUDAMED
Registry facts
- Registries
- FDA GUDID 72
- EUDAMED 45
- FDA 510(k) 3
- Device classes
- FDA Class II 71
- EU Class IIb 22
- EU Class I 10
- EU Class IIa 4
- Top EMDN categories
- Electrosurgery devices, single-use 9
- High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body for skin resurfacing, tattoo 8
- Instruments for functional explorations and therapeutic interventions 8
- Devices for general and specialist dressings - various 6
- Equipment without an intended medical purpose intended to be used to reduce, remove or destroy adipose tissue 4
- Various devices not included in other classes 1
- Sites and related companies
- Identifiers
- EUDAMED SRN KR-MF-000010116
- DUNS 689842183
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What CLASSYS Inc. makes
CLASSYS Inc. manufactures devices for dermatological and surgical procedures, including intradermal radio-frequency ablation systems like the Wav30 and Fraxis Main Unit, as well as carbon dioxide and solid-state laser systems such as the Secret PRO Set Package and Max-64C. Their portfolio also includes radio-frequency skin contouring applicators (e.g., VOLNEWMER F tip and VOLNEWMER S tip) and electrosurgical tools, including monopolar single-use electrodes and electrosurgical systems. Diode and frequency-doubled solid-state laser systems (e.g., QUADESSY Neutral and Deeplus hand pieces) are also part of their offerings.
CLASSYS Inc.’s devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries.
Catalogue
Search and filter all 108 devicesShowing 1-50 of 108
Company details
- EUDAMED SRN
- KR-MF-000010116
- DUNS number
- 689842183
- EUDAMED status
- Active
- EUDAMED registered name
- CLASSYS
- Registered address
- 208, Teheran-ro, 06220, Seoul, South Korea
- Phone
- +82-2-6313-2245
- PRRC contact
- Kim Chang Seop
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 12 May 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 806197 Active
Quality management system EU MDR
- Issued
- 7 Aug 2026
- Expires
- 12 May 2030
- Reason
- Add device or group
Frequently asked questions
How many devices does CLASSYS Inc. have in the registry?
The registry currently lists 108 devices for CLASSYS Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CLASSYS Inc.'s devices?
Among its 50 most recently registered devices, CLASSYS Inc. has devices listed in EUDAMED (31 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CLASSYS Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for CLASSYS Inc.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for CLASSYS Inc.?
EUDAMED lists 1 certificate for CLASSYS Inc. (quality management system) under MDR. The most recent was issued on 7 Aug 2026.
What are the newest devices from CLASSYS Inc. in the registry?
The most recently registered devices listed for CLASSYS Inc. include Sterile micro needle electrodes, Extra Large Tip, ALPHA SHIELD T Pad and Slim Tip.