Eu Mdd Eu Md Class 2a On The Market 🇰🇷 South Korea

DO-ALL

DOALL · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
08800145301640
Basic UDI-DI Code
B-08800145301640
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
MDD Annex V 2195-MED-391430001

Available In Countries

🇩🇪 Germany

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