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Heuron Co., Ltd.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000008614 FEI 3016727312

Heuron Co., Ltd. is a medical device manufacturer based in South Korea, with 9 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 15 Nov 2026.

Devices
9
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 5
  • FDA 510(k) 4
  • EUDAMED 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 7
  • EU Class IIa 2
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000008614
  • FDA FEI 3016727312
  • DUNS 694971646

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
KTR Europe GmbHDE

Catalogue9

Newest first, rows 1-9 of 9

  • Veuron-Brain-mN1 V-B-mN1-01

    Listed Registry: GUDID Class:II

  • Veuron-Brain-pAb3 AD-AWC03

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Heuron ICH ST-ICT01

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Veuron-Brain-pAb2 Ref K213801

    Active Regimes: 510(k) Registry: 510(k)GUDID Class:II

  • Veuron-Brain-mN1 Ref K203279

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Veuron-Brain-pAb3 Ref K231642

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Heuron ICH Ref K233247

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Veuron-Brain-pAb Ref V-B-pAb-01

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:IIa

  • Heuron IPD Ref H-PD-D05

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000008614
FDA FEI number
3016727312
DUNS number
694971646
EUDAMED status
Active
EUDAMED registered name
Heuron Co., Ltd.
Registered address
150, Yeongdeungpo-ro, 07292, Seoul, South Korea
PRRC contact
Jinkyung Park(public in EUDAMED)

Frequently asked questions

How many devices does Heuron Co., Ltd. have in the registry?

The registry currently lists 9 devices for Heuron Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Heuron Co., Ltd.'s devices?

Among its 9 most recently registered devices, Heuron Co., Ltd. has devices listed in EUDAMED (2 devices), FDA 510(k) (4 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Heuron Co., Ltd.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Heuron Co., Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Heuron Co., Ltd. in the registry?

The most recently registered devices listed for Heuron Co., Ltd. include Veuron-Brain-mN1 V-B-mN1-01, Veuron-Brain-pAb3 AD-AWC03, Heuron ICH ST-ICT01 and Veuron-Brain-pAb2.

Generated automatically from registry data and not verified by a human reviewer.