# SPECLIPSE, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/speclipse-inc>
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: KR-MF-000026775
- FDA FEI: 3013697074
- DUNS: 694509874

## Figures

- Devices: 8
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 6, EUDAMED 5, FDA 510(k) 1
- Device classes: FDA Class II 5, EU Class IIb 2, EU Class IIa 1
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 2 devices
- EMDN [V90 Various devices not included in other classes](https://devicerts.com/categories/emdn/V90): 1 devices

## Sites and related companies

- Authorised representative: [Qualrep Services B.V.](https://devicerts.com/representatives/qualrep-services-bv-nl-ar-000000537) (Netherlands)

## Devices

The first 8 of 8, in the order of the canonical page, which lists them all.

- [Qmode 01](https://devicerts.com/devices/qmode-01) · Class II · EUDAMED, GUDID · status: Active
- [Picofy 01](https://devicerts.com/devices/picofy-01) · Class II · GUDID · status: Active
- [Pico Shining(Picofy) 01](https://devicerts.com/devices/pico-shining-picofy-01) · Class II · EUDAMED, GUDID · status: Active
- [Pico Shining(Pico-K) 01](https://devicerts.com/devices/pico-shining-pico-k-01) · Class II · GUDID · status: Active
- [Pico Shining (Pico-K; Picofy)](https://devicerts.com/devices/pico-shining-pico-k-picofy-gex) · ref K261214 · Class II · 510(k) · status: Active · decision 2026-05-11
- [Pico-K](https://devicerts.com/devices/pico-k-pk) · ref PK · Class IIb · EUDAMED, GUDID · status: Active
- [Spectra-Scope Standalone](https://devicerts.com/devices/spectra-scope-standalone-spcs-ifu-sp03-ce) · ref SPCS-IFU-SP03(CE) · Class IIa · EUDAMED · status: Active
- [Bellus-Q](https://devicerts.com/devices/bellus-q-bq) · ref BQ · Class IIb · EUDAMED, GUDID · status: Active

## Source and citation

- Cite as: SPECLIPSE, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/speclipse-inc (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/speclipse-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/speclipse-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.