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Sterile Micro Needle ELLISYS ST

FDA UDI

Class II (US FDA UDI)

by Chungwoo Co., Ltd.

Identity

Trade Name
Sterile Micro Needle ELLISYS ST FDA UDI
Generic Name
Resective skin contouring/liposuction system needle/cannula kit FDA UDI
Model / Reference
CWM-930S_ELLISYS ST-S36 FDA UDI

Identifiers

Primary DI / UDI-DI
08809495931224 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Resective skin contouring/liposuction system needle/cannula kit 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Resective skin contouring/liposuction system needle/cannula kit

Sterile Micro Needle ELLISYS ST by Chungwoo Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resective skin contouring/liposuction system needle/cannula kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chungwoo Co., Ltd.

Sources (1)

  • FDA UDI e9183cef-8aa6-4ccb-a6ce-7a0eea928cc3 33 fields · synced May 30, 2026