Basic Information
- Primary DI
- 08800145301008
- Basic UDI-DI Code
- B-08800145301008
- Reference
- MICRO NEEDLE
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- DOALL
Additional Description
A microneedling device is a medical device that stimulates the skin with fine needles to help absorb drugs. The needle length is 0.25 mm or longer for hospital use(not for personal use) which can pierce the stratum corneum of the skin without pain. Since the drug is administered through the skin that are difficult to deliver through the oral route can be delivered through the skin and promote absorption of the drug into the bloodstream. It can initiate action more quickly and increase the immune response to immune response cells (Langerhans cells) present in the skin, so it can be used for skin-targeted drug delivery and has the advantage of allowing self-administration.
CND Nomenclature Codes
| Code | Description |
|---|---|
| A019002 | ACUPUNCTURE NEEDLES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 2195-MED-391430001 | Szutest Uygunluk Değerlendirme A.Ş. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).