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PlaDuo PRO System

FDA UDI

Class II (US FDA UDI)

by shenb Co., Ltd.

Identity

Trade Name
PlaDuo PRO System FDA UDI
Generic Name
Nitrogen plasma skin surface treatment system FDA UDI
Device Name
Brand Name: PlaDuo PRO System (PlaDuo System) Model: PlaDuo PRO System FDA UDI
Model / Reference
PlaDuo PRO System FDA UDI
Description
Brand Name: PlaDuo PRO System (PlaDuo System) Model: PlaDuo PRO System FDA UDI

Identifiers

Primary DI / UDI-DI
08800017101422 FDA UDI
510(k) Number
K232223 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Nitrogen plasma skin surface treatment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nitrogen plasma skin surface treatment systemArgon-enhanced electrosurgical system gas delivery unit

PlaDuo PRO System by shenb Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Argon-enhanced electrosurgical system gas delivery unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
shenb Co., Ltd.

Sources (1)

  • FDA UDI d74aa88d-80d6-43dd-b503-5a36d1990902 34 fields · synced May 31, 2026