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861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° marine

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 355538Model Essential COMFORTABLE

by Sigvaris, Inc.

Identity

Trade Name
Essential COMFORTABLE EUDAMED
861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° marine FDA UDI
Generic Name
Compression/pressure sock/stocking, single-use FDA UDI
Device Name
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device. FDA UDI
Model / Reference
355538 EUDAMEDFDA UDI
Essential COMFORTABLE EUDAMED
Description
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device. FDA UDI

Identifiers

Catalog Number
355538 FDA UDI
Primary DI / UDI-DI
07613378277658 EUDAMEDFDA UDI
Basic UDI-DI
7611711ECFBX EUDAMED
FDA Product Code
FQL FDA UDI
EMDN Code
M030405 COMPRESSION STOCKINGS EUDAMED
GMDN Term
Compression/pressure sock/stocking, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
880.5780 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Compression/pressure sock/stocking, single-use

861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° marine by Sigvaris, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Compression/pressure sock/stocking, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sigvaris, Inc.

Sources (2)

  • FDA UDI 6e1ab408-e8e7-4b6c-a5d4-36febeb5ec2e 36 fields · synced Jul 27, 2026
  • EUDAMED 2c36c896-ccb0-4141-bcf1-cfc5118a97d1 61 fields · synced Jul 27, 2026