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Stellar Fluorescence Camera Head

by Guangdong Optomedic Technologies, Inc.

Ref SC20E

Stellar Fluorescence Camera Head (SC20E) is an endoscopic video image processing unit (EU MDR Class I; FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Guangdong Optomedic Technologies, Inc., registered in EUDAMED on 26 Sep 2024 (Basic UDI-DI 697303129SX20E01J9), cleared under FDA 510(k) K241530 on 7 Aug 2024 and listed in FDA GUDID since 15 Aug 2024 (UDI-DI 06973031299412), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241530

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697303129SX20E01J9 Basic UDI-DI 06973031299412UDI-DIDate26 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06973031299412 UDI-DI Date15 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241530 Date7 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697303129SX20E01J9 registered 26 Sep 2024 Active
  • FDA 510(k) K241530 decided 7 Aug 2024 Active
  • FDA GUDID UDI-DI 06973031299412 listed 15 Aug 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241530
  2. Listed FDA GUDID 06973031299412
  3. Registered EUDAMED 697303129SX20E01J9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Endoscopic video image processing unit
Device name
Fluorescence Camera Head
Model / reference
SC20E
Primary DI / UDI-DI
06973031299412
Basic UDI-DI
697303129SX20E01J9
Direct marketing DI
06973031299412
510(k) Number
FDA product code
GCJ
EMDN code
Z12020405 Surgical cameras
GMDN term
Endoscopic video image processing unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Hydrogen Peroxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000011588
Authorised representative
Share info GmbH DE-AR-000005132

Similar devices in this category

Other devices filed under SURGICAL CAMERAS.

Other devices from Guangdong Optomedic Technologies, Inc.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)