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SPECLIPSE, Inc.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000026775 FEI 3013697074

SPECLIPSE, Inc. is a medical device manufacturer based in South Korea, with 8 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb and IIa) as of 14 Nov 2026.

Devices
8
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 6
  • EUDAMED 5
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 5
  • EU Class IIb 2
  • EU Class IIa 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000026775
  • FDA FEI 3013697074
  • DUNS 694509874

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
Qualrep Services B.V.NL

Catalogue8

Newest first, rows 1-8 of 8

  • Qmode 01

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

  • Picofy 01

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

  • Pico Shining(Picofy) 01

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

  • Pico Shining(Pico-K) 01

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

  • Pico Shining (Pico-K; Picofy) Ref K261214

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

  • Pico-K Ref PK

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

  • Spectra-Scope Standalone Ref SPCS-IFU-SP03(CE)

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Bellus-Q Ref BQ

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

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000026775
FDA FEI number
3013697074
DUNS number
694509874
EUDAMED status
Active
EUDAMED registered name
Speclipse, Inc.
Registered address
232, Sandan-ro, 15433, Danwon-gu, Ansan-si, Gyeonggi-do, South Korea
Phone
+82 31 698 2269
PRRC contact
Cheol Woo Kim(public in EUDAMED)

Frequently asked questions

How many devices does SPECLIPSE, Inc. have in the registry?

The registry currently lists 8 devices for SPECLIPSE, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list SPECLIPSE, Inc.'s devices?

Among its 8 most recently registered devices, SPECLIPSE, Inc. has devices listed in EUDAMED (5 devices), FDA 510(k) (1 device) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SPECLIPSE, Inc.'s devices fall under?

Among its 8 most recently registered devices, the classes recorded for SPECLIPSE, Inc.'s devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What are the newest devices from SPECLIPSE, Inc. in the registry?

The most recently registered devices listed for SPECLIPSE, Inc. include QMODE 01, PICOFY 01, PICO SHINING(PICOFY) 01 and PICO SHINING(PICO-K) 01.

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