← Back to catalogue

HeltiQ Cohesive bandage

EUDAMED

Class I (EU MDR)

Ref 311015RModel 4m*8cm

by RFX+CARE Manufacturing Co., Ltd.

Identity

Trade Name: HeltiQ Cohesive bandage EUDAMED
Device Name: bandage EUDAMED
Model / Reference: 4m*8cm EUDAMED
311015R EUDAMED

Identifiers

Primary DI / UDI-DI: 08717484792377 EUDAMED
Basic UDI-DI: B-08717484792377 EUDAMED
EMDN Code: M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Compression/pressure sock/stocking, reusable

HeltiQ Cohesive bandage by RFX+CARE Manufacturing Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Compression/pressure sock/stocking, reusable.

PREGNANCY CORSET-M — HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ · Class I
CICATREX MASS FUSS/BEIN NAT.F. — Thuasne Deutschland GmbH · Class I
JOBST Elvarex — Bsn-Jobst, Inc. · Class II
Physiologix Ultimate Carpal Tunnel Brace — Fleming Medical · Class I
Female compression pants — Eto Garments ApS · Class I
BabyBelt — Anita Dr. Helbig GmbH · Class I
JOBST Style — BSN MEDICAL, INC. · Class II
Female compression bodystocking — Eto Garments ApS · Class I

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: RFX+CARE Manufacturing Co., Ltd.
EUDAMED SRN: CN-MF-000002971
Authorised Representative: RFX+Care International A/S DK-AR-000001768

Sources (1)

EUDAMED fb08c78c-659a-4753-95d1-509999283100 61 fields · synced Jul 17, 2026