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ComfyHealth

FDA UDI

Class I (US FDA UDI)

by Comfy Health Group Co., Ltd.

Identity

Trade Name
ComfyHealth FDA UDI
Generic Name
Wrist/hand orthosis FDA UDI
Device Name
BRACOO EP42 Elbow Shielder Sleeve 3D Ergo Pad w/ Wrap Support / Grade 4 Gary XL-SIZE FDA UDI
Model / Reference
EP42 FDA UDI
Description
BRACOO EP42 Elbow Shielder Sleeve 3D Ergo Pad w/ Wrap Support / Grade 4 Gary XL-SIZE FDA UDI

Identifiers

Primary DI / UDI-DI
04719879644739 FDA UDI
FDA Product Code
MRI FDA UDI
GMDN Term
Wrist/hand orthosis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3490 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

Yes

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wrist/hand orthosis

ComfyHealth by Comfy Health Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wrist/hand orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Comfy Health Group Co., Ltd.

Sources (1)

  • FDA UDI 287d66c1-7fa2-4498-9c9f-a24babe5d1bc 33 fields · synced May 31, 2026