RecensMedical, Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000013578
- Devices
- 6
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What RecensMedical, Inc. makes
RecensMedical, Inc. manufactures cryosurgical systems, including devices that use cryogen gas and mechanical methods to deliver controlled freezing for medical procedures. Their portfolio includes systems like TargetCool and OcuCool for targeted tissue ablation, as well as CryoVIVE for broader cryosurgical applications.
The company’s devices are classified under EU Class II and Class IIa regulations, with listings in the EUDAMED database, FDA’s 510(k) premarket notification program, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Korea.
Catalogue
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Registry: GUDID
- Regimes: CE MDR CE MDD Registry: GUDID
OcuCool Ref DEN230011
Regimes: De Novo Registry: De NovoCryoVIVE Ref K203481
Regimes: 510(k) Registry: 510(k)TargetCool Ref UM-001-CV
Regimes: CE MDR CE MDD 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- KR-MF-000013578
- DUNS number
- 694808508
- EUDAMED status
- Active since 2022
- EUDAMED registered name
- RecensMedical, Inc.
- Registered address
- 18468, #908, SK V1 center, 830 Dongtansunhwan-daero, Dongtan-gu, Hwaseong-si, Gyeonggi-do, South Korea
- Website
- www.recensmedical.com/
- [email protected]
- Phone
- +82 31 8043 3064
- PRRC contact
- Eunhee Jo
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 21 Nov 2030
3EC International a.s. 2265 1 certificate
- 2025-MDR/QS-057/B Active
Quality management system EU MDR
- Issued
- 31 Jul 2026
- Expires
- 21 Nov 2030
- Reason
- Mnf data change
Frequently asked questions
How many devices does RecensMedical, Inc. have in the registry?
The registry currently lists 6 devices for RecensMedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list RecensMedical, Inc.'s devices?
Among its 6 most recently registered devices, RecensMedical, Inc. has devices listed in EUDAMED (2 devices), FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do RecensMedical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for RecensMedical, Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for RecensMedical, Inc.?
EUDAMED lists 1 certificate for RecensMedical, Inc. (quality management system) under MDR. The most recent was issued on 31 Jul 2026.
What are the newest devices from RecensMedical, Inc. in the registry?
The most recently registered devices listed for RecensMedical, Inc. include TargetCool-e RH-PD06W, OcuCool ODM-E01, TargetCool RM-DC04U and OcuCool.