Dialfix 11 01

Dialfix 11 01 is a skin-closing tension device (FDA Class I; FDA product code MKY, System, Skin Closure) made by Dfix, listed in FDA GUDID since 28 Jan 2023 (UDI-DI 08800125000020), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800125000020 UDI-DI	Date28 Jan 2023Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 08800125000020

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Dialfix 11
Generic name: Skin-closing tension device
Model / reference: 01

Primary DI / UDI-DI: 08800125000020
FDA product code: MKY
GMDN term: Skin-closing tension device

Device class: Class I
Regulation number: 878.4320
GUDID distribution status: In Commercial Distribution

Similar devices

Other devices filed under FDA product code MKY (System, Skin Closure).

Other devices from Dfix

Sdfix 01

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Dialfix 24 01

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Dialfix Plus 3 01

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Dialfix 15 01

Class I

See all devices from Dfix →

Properties

Supplied sterile
Single use
Implantable
Premarket exempt
Manufacturing date

Other properties (10, all answered No)