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Sterile Micro Needle

FDA UDI

Class II (US FDA UDI)

by Chungwoo Co., Ltd.

Identity

Trade Name
Sterile Micro Needle FDA UDI
Generic Name
Resective skin contouring/liposuction system needle/cannula kit FDA UDI
Model / Reference
CWM-930S_ELLISYS TIP-1 FDA UDI

Identifiers

Primary DI / UDI-DI
08809495931217 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 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 b68d9d72-1945-42c7-bbe8-38beb24600a6 33 fields · synced May 30, 2026