FDA.reportPublic FDA data

BELLUS MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103929913010392991BELLUS MEDICAL, LLC1N2026-01-01207 Mockingbird Ln Johnson City TN US 37604

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850035498279SP MicroPen EVO Microneedling Cartridge - MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient use.888.372.3982customerservice@crownaesthetics.com
00850060751004SkinPen Precision Elite - SPP Elite Microneedling Handpiece1-888-372-3982customerservice@crownaesthetics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1621201268332055K241400SkinPen Precision Elite SystemQAI2024-08-29
1621201883156920K212558MicroPen EVOQAI2021-11-24
1621201182477325K200017Eclipse DermaFlex CannulaFMI2020-11-05
1621201859709144K172938Disposable Sterile NeedleFMI2018-06-14
1621201783179445DEN160029SkinPen Precision SystemQAI2018-03-01
1621201328242721BK241095
1621201219769886BK170136
1621201700531547BK130079
1621201853523143BK120057
1621201330772641
1621201345981605
1621201408075753
1621201518806553
1621201536407407

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QAI32024-08-29
FMI22020-11-05

NDC#

GUDID#