Development, manufacture and distribution of medical microneedling and mesotherapy devices from Berlin
amiea med (MT.DERM GmbH)
New on Amplifa
About amiea med
amiea med is a brand of MT.DERM GmbH, based in Berlin, dedicated to research and development, manufacturing, training and the distribution of medical-aesthetic devices. Its core business is the precise delivery of substances into the skin, in particular for medical microneedling and mesotherapy. The flagship product EXCEED UNLIMITED is a medical microneedling device with a handpiece and sterile single-use cartridge (6 needles), a needle penetration depth of up to 1.5 mm and a frequency of up to 150 Hz; the penetration depth is documented at ±0.15 mm. In 2024, the system received dual FDA clearance (K233709) for facial wrinkles and acne scars. The products carry the “Made in Germany” label
- Site
- Berlin
- Processes
- Medical microneedling (EXCEED UNLIMITED, FDA-cleared K233709), Microneedling treatment of wrinkles (Needle depth 0.25–1.5 mm, max. 1.9 mm), Microneedling treatment of scars (Needle depth 1.5–1.9 mm), Mesotherapy (injection of substances into the skin), R&D, manufacturing, training and distribution of medical-aesthetic devices, Training, Distribution of medical aesthetic devices, R&D and manufacturing of microneedling and mesotherapy devices
- Materials
- Medical microneedling device, Mesotherapy
- Certificates
- ISO 13485
- Founded
- 1998
- Industries
- Medical Supplies, Aesthetic Medicine, Dermatology, Medical Devices, Cosmetic Devices/Tattoo Equipment
- 01
Research & Development
- 02
Manufacturing
- 03
Quality Inspection
- 04
Training
- 05
Distribution
Technology & Processes
Medical microneedling device
Handpiece with sterile single-use cartridge (6 needles), up to 150 Hz, penetration depth up to 1.5 mm (±0.15 mm).
Mesotherapy
Process for injecting substances into the skin.
Locations
Berlin
DEHeadquarters / Development, Manufacturing, Distribution
- EXCEED UNLIMITED (microneedling device, up to 150 Hz)
- Exceed (predecessor model)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Medical microneedling (EXCEED UNLIMITED, FDA-cleared K233709)Inspection | Penetration depth ±0.15 mm | – | – | – | Stainless steel needles (6 precision needles, not verbatim |
| Microneedling treatment of wrinkles (Needle depth 0.25–1.5 mm, max. 1.9 mm)Inspection | ±0.15 mm | – | – | – | – |
| Microneedling treatment of scars (Needle depth 1.5–1.9 mm)Inspection | ±0.15 mm | – | – | – | – |
| Mesotherapy (injection of substances into the skin)Inspection | – | – | – | – | – |
| R&D, manufacturing, training and distribution of medical-aesthetic devicesEngineering | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Medical microneedling device (handpiece with sterile single-use cartridge, 6 needles, up to 150 Hz) | amiea med / MT.DERM EXCEED UNLIMITED | – | max. needle penetration depth 1.5 mm; needle protrusion 1.39 mm; frequency up to 150 Hz | – | Berlin |
| Medical microneedling device | MT.DERM Exceed (predecessor) | – | – | – | Berlin |
Additional services
Quality
amiea med operates an ISO 13485-certified quality management system; the Exceed platform is additionally FDA-cleared (K233709).
| Evidence | Berlin |
|---|---|
| ISO 13485 |
History
- 1998
Founded
- 2012
Start of medical microneedling expertise
- 2024
FDA clearance (K233709) for EXCEED UNLIMITED for the treatment of facial wrinkles and acne scars