FDA.reportPublic FDA data

mixsoon Derma Booster PRO

Primary DI
08809732914683
Brand
mixsoon Derma Booster PRO
Company
Haho Medi
Model
mixsoon Derma Booster PRO
Device description
personal home care facial massage device
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809732914683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809732914683088097329146838809732914683

GMDN Terms#

Term, Definition table
TermDefinition
Tissue processor IVD, automated/semi-automatedAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8201020288673careme@caremekor.com

Regulatory Flags#

DUNS number
987445367
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true
No natural rubber latex
true

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