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Organization name
UDI-DI code
Reference / catalog number

STRAP4U ICE HOT HEALTH DENT X1 — Class I MDR by CREATION XXI

MD Atlas
CREATION XXI

EUDAMED last updated this device on Oct 23, 2025

STRAP4U ICE HOT HEALTH DENT X1

3770011095POD_01ZL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CREATION XXI
UDI-DI code: 37700110951790
Reference / catalog number: S4U -S - D

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Manufacturer information

Organization name: CREATION XXI
SRN: FR-MF-000012697
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Oct 15, 2020	Still on market

Device identification

Trade name: STRAP4U ICE HOT HEALTH DENT X1
UDI-DI code: 37700110951790
Basic UDI-DI: 3770011095POD_01ZL
Reference / catalog number: S4U -S - D
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Système associant un POD STRAP4U ICE COMFORT DENT qui s'applique directement sur le visage à l'aide d'une bande élastique s'appuyant sur le visage grâce à un point d'appui menton et une fixation ajustable avec un réglage auto-agrippant. Le POD STRAP4U ICE COMFORT DENT est un dispositif médical de cryothérapie / thermothérapie destiné à soulager et traiter les douleurs dentaires. Indiqué pour le traitement des douleurs dentaires, inflammations et œdèmes en post-opératoire après une chirurgie dentaire (extractions, dents de sagesse, implants, œdèmes, caries, parodonties, inflammations). Son matériau innovant de transfert thermique permet une diffusion longue, régulière et profonde du froid ou de la chaleur en toute sécurité. Application directe sur la peau sans brulure. Il offre un confort et un soin optimal adapté à la sensibilité du visage. Dispositif élaboré avec des matériaux naturels et hypoallergéniques.
Additional information URL: https://strap4u.com/accueil/strap4u-dent/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

POD STRAP4U ICE COMFORT D.M.P.3770011095POD_01ZLOn the market POD STRAP4U ICE HOT HEALTH3770011095POD_04ZSOn the market POD STRAP4U ICE HOT HEALTH DENT3770011095POD_01ZLOn the market POD STRAP4U ICE HOT HEALTH DENT3770011095POD3YOn the market STRAP4U - BLEU - T23770011095STRAP_01ZWOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.