Medical Park Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000026310
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
What Medical Park Co., Ltd. makes
Medical Park Co., Ltd. manufactures the BEXCORE Breast Biopsy System, a device designed for breast tissue sampling, along with associated biopsy needles. This system is intended for use in diagnostic procedures to obtain tissue samples for histopathological examination.
The company’s portfolio is regulated under Class II medical devices in the United States, with the BEXCORE Breast Biopsy System listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the US.
Catalogue
- Regimes: CE MDD Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDD Registry: EUDAMED
- Regimes: CE MDD Registry: EUDAMEDGUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Registry: GUDID
BEXCORE Breast Biopsy System, Biopsy Needle Ref K171890
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- KR-MF-000026310
- EUDAMED status
- Active
- EUDAMED registered name
- MedicalPark CO.,LTD.
- Registered address
- 7, Saneop-ro 156beon-gil, Gwonseon-gu,, 16648, Suwon-si, South Korea
- [email protected]
- Phone
- +82 70-4800-6532
- PRRC contact
- Kichan An
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 Apr 2031
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 40968713-1 Active
Quality management system EU MDR
- Issued
- 14 Apr 2026
- Expires
- 13 Apr 2031
FDA establishments
- Medicalpark Co. Ltd Suwon-si Gyeonggi · KR FEI 3012936513
Frequently asked questions
How many devices does Medical Park Co., Ltd. have in the registry?
The registry currently lists 9 devices for Medical Park Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Park Co., Ltd.'s devices?
Among its 9 most recently registered devices, Medical Park Co., Ltd. has devices listed in EUDAMED (5 devices), FDA 510(k) (1 device) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medical Park Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Medical Park Co., Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Medical Park Co., Ltd.?
EUDAMED lists 1 certificate for Medical Park Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-04-14.
What are the newest devices from Medical Park Co., Ltd. in the registry?
The most recently registered devices listed for Medical Park Co., Ltd. include BEXCORE FAST KIT, BEXCORE NEEDLE, BEXCORE Breast Biopsy System BXS100 and BEXCORE Breast Biopsy Needle BXC145.
Which FDA establishments are linked to Medical Park Co., Ltd.?
1 FDA establishment is linked to Medical Park Co., Ltd. in the registry; they are listed on the company page.