FDA.reportPublic FDA data

Demetra

Primary DI
05415334001763
Brand
Demetra
Company
Barco NV
Model
Demetra
Device description
Demetra BDEM-01
Published
2020-06-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSNLight based imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSNLight Based ImagingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192829000Demetra BDEM-01 DermatoscopeBarco N.V.2019-12-13PSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415334001763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334001763054153340017635415334001763

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, digitalAn electrically-powered, hand-held instrument intended to be used for the microscopic examination of the external skin layers through the production of digital images (i.e. without direct optical view). The device has a built-in light source(s) and an electronic magnification system that provides the user with digital images of the structures of the epidermis and epidermal-dermal junction for visualization during dermatoscopy (also known as dermascopy). This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)302-7939service.medical.usa@barco.com

Regulatory Flags#

DUNS number
371618773
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334053168BarcoMDSC-8532K93531112026-06-02
05415334053335BarcoMDSC-8532K93531212026-06-02
05415334056411BarcoMDSC-8527K93530121X2026-06-02
05415334056428BarcoMDSC-8532K93530131X2026-06-02
05415334056435BarcoMDSC-8527K93530181X2026-06-02
05415334056442BarcoMDSC-8532K93530191X2026-06-02
05415334061750BarcoMDNC-6121K9300360C2X2026-06-02
05415334057265Nio Color 8MPMDNC-8132K9300830B2X2026-05-07
05415334062412Nexxis ORNexxis systemK96104262026-04-28
05415334036277Nexxis ORNexxis systemK96104202021-06-28
05415334057258Eonis 32”MDRC-8132K9350830B2X2026-04-13
05415334050020BarcoMDSC-8532 K93530182025-12-22
05415334000148Nio 2MPE 2620 S2016-06-30
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334000155Barco Mammo TomosynthesisMDMG-52212016-06-30
05415334000162Coronis 3MP LEDMDCG-32212016-06-30
05415334000247Coronis Fusion 4MP LEDMDCC-4330K9301625A2016-06-30
05415334000261Coronis Fusion 6MP LEDMDCC-6430K9301635A2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013961404DermoSight DermatoscopeDEEPX HEALTH, LLCPSN2025-06-19
00860013961411DermoSight SoftwareDEEPX HEALTH, LLCPSN2025-06-19
08602920003066VivaScope SystemCaliber Imaging & Diagnostics, Inc.PSN2023-02-16
05415334036192DemetraBarco NVPSN2021-06-28
00628451918035MoleMateMedX Health CorpPSN2016-09-22
00628451918004MoleMateMedX Health CorpPSN2016-09-22
00628451918073SIMSYSMedX Health CorpPSN2016-09-22
00860292000306VivaScope SystemCaliber Imaging & Diagnostics, Inc.PSN2016-08-22