FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809732914683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809732914683088097329146838809732914683

GMDN Terms

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

Contacts

PhoneEmail
+8201020288673careme@caremekor.com

Regulatory Flags

DUNS number
987445367
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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