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Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
CREATION XXI

EUDAMED last updated this device on Aug 29, 2024

POD STRAP4U ICE HOT HEALTH DENT

3770011095POD3Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CREATION XXI
UDI-DI code: 37700110955446
Reference / catalog number: POD S4U_IHH_D

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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	Aug 29, 2024	Still on market

Device identification

Trade name: POD STRAP4U ICE HOT HEALTH DENT
UDI-DI code: 37700110955446
Basic UDI-DI: 3770011095POD3Y
Reference / catalog number: POD S4U_IHH_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: Dispositif médical ( DM1 ), soulage et traite par cryothérapie ou thermothérapie les douleurs dentaires. Il est indiqué pour le traitement des douleurs dentaires, inflammations et œdèmes en post-opératoire après une chirurgie dentaire ( extraction, dents de sagesse, implants, œdème, caries, parodontie, inflammations ). Produit élaboré avec des matériaux naturels, hypoallergéniques et diffuseurs. Produit stérilisable et désinfectable. POD STRAP4U ICE HOT HEALTH DENT s'insère dans le dispositif de maintien élastique ajustable : STRAP4U DENT.
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 STRAP4U - BLEU - T23770011095STRAP_01ZWOn the market STRAP4U - ROUGE - 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.