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

BOMTECH

BOMTECH · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1

Basic Information

Primary DI
08800016000368
Basic UDI-DI Code
B-08800016000368
Reference
RF COMBO JECTOR
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market
Manufacturer
BOMTECH

Additional Description

- Intended Purpose This product is that injects a certain amount of medicine and delivers a high frequency to coagulation of tissue. - Configuration This device consists of Main body, Cradle, RF fixer and Adaptor. This product is intended to be used by charging battery (3.7 V 3000 mAh) inside the product through adapter (AC 100 240 V, 50/60 Hz, 0.5 0.3 A / DC 5 V, 3.0 A) and cradle. When charging with adapter, connect the adapter to the DC jack of the product and ch arge it. It consists of an LCD panel, control components, high frequency output section and multi needle. RF needle and Multi needles deliver high frequency energy to the human body and inject a certain amount of medicine. Bipolar electrode type RF needle and infusion multi needles are connected to the unit and used for coagulation and medicine delivery of patient tissue.

CND Nomenclature Codes

Code Description
Z12030302 SYRINGE PUMPS

Certificates

Type Number
MDD Annex II Section 4 1434-MDD-386/2020

Available In Countries

🇩🇪 Germany 🇵🇱 Poland

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