FDA.reportPublic FDA data

MT.DERM GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066348743006634874MT.DERM GmbH1N2026-01-01Blohmstrasse 37-61 Berlin DE 12307

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2226171563332249K233709Exceed UnlimitedQAI2024-02-23
2226171723255579K182407Exceed Microneedling deviceQAI2019-07-19
2226171247997946K180778Exceed Microneedling DeviceQAI2018-09-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QAI52024-02-23

PMN#

GUDID#

Bio Touch Aero - The Bio touch Aero is a variant of Exceed Unlimited. The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50- 60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.

MT.DERM GmbH

2026-05-22

Exceed Unlimited - The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50- 60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.

MT.DERM GmbH

2026-05-22