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Organization name
UDI-DI code
Reference / catalog number

STRAP4U ICE COMFORT — Class I MDR by CREATION XXI

MD Atlas
CREATION XXI

EUDAMED last updated this device on Feb 2, 2022

STRAP4U ICE COMFORT

3770011095POD_02ZN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CREATION XXI
UDI-DI code: 37700110950878
Reference / catalog number: S4U - IC

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Manufacturer information

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

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Dec 4, 2019	Still on market

Device identification

Trade name: STRAP4U ICE COMFORT
UDI-DI code: 37700110950878
Basic UDI-DI: 3770011095POD_02ZN
Reference / catalog number: S4U - IC
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: Dispositif médical de cryothérapie / thermothérapie destiné à soulager et traiter les blessures articulaires ( entorse, arthrose ), musculaires ( déchirure, hématome) et inflammatoires ( tendinites et inflammations diverses ). Son matériau innovant de transfert thermique permet une diffusion longue, régulière et profonde du froid ou de la chaleur en toute sécurité ainsi qu'une large diffusion dépassant la surface de contact du dispositif sur la peau. Application directe sur la peau sans brûlure. Produit élaboré avec des matériaux naturels et hypoallergéniques.
Additional information URL: https://strap4u.com/accueil/strap4u-ice-comfort/
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

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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.