kegel Hydrogel Dressing Island

by Jiangsu NewValue Medical Products Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06970206820808 UDI-DI	Date22 Jun 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: kegel Hydrogel Dressing
Generic Name: Wound hydrogel dressing, non-antimicrobial
Model / Reference: Island

Primary DI / UDI-DI: 06970206820808
FDA Product Code: NAE
GMDN Term: Wound hydrogel dressing, non-antimicrobial

Device Class: Class I
Regulation Number: 878.4022
GUDID distribution status: In Commercial Distribution

Other devices from Jiangsu NewValue Medical Products Co., Ltd.

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kegel Hydrocolloid Dressing Island

Class I
kegel Silicone Scar Sheets

Class I
Ourmed Hydrocolloid Dressing Standard

Class I

See all devices from Jiangsu NewValue Medical Products Co., Ltd. →

Properties

Sterile
Single Use
Premarket Exempt
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No