AccessGUDID - DEVICE: MEICET (06975980570017)

GUDID

Device Identifier (DI) Information

Brand Name: MEICET
Version or Model: MC10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai May Skin Information Technology Co., Ltd.

Primary DI Number: 06975980570017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544352306 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47158	Dermatoscopy system	A computer-based image storage and retrieval picture archiving and communication system (PACS) that together with a connected electronic dermatoscope, captures, stores, recalls, and supports dermatological analyses/diagnoses through preselected digital images supplemented with three-dimensional (3-D) information. It typically consists of an image acquisition electronic dermatoscope, base station, monitor, computer, printer, application software, and a trolley. It will facilitate image transmission to any part of the hospital or telemedicine without the need for physical copying/transport, and gives direct access to stored images for physicians, surgeons, referring physicians.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCJ	Device, Skin Potential Measurement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9086e571-44b1-424b-846b-73af418a7127
Public Version Date: February 06, 2023
Public Version Number: 1
DI Record Publish Date: January 28, 2023