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Organization name
UDI-DI code
Reference / catalog number

STRAP4U_ROSE_T1 — Class I MDR by CREATION XXI

MD Atlas
CREATION XXI

EUDAMED last updated this device on Feb 26, 2024

STRAP4U_ROSE_T1

3770011095STRAP_94

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CREATION XXI
UDI-DI code: 37700110954838
Reference / catalog number: S4U - ROSE - T1

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Manufacturer information

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

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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.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: STRAP4U_ROSE_T1
UDI-DI code: 37700110954838
Basic UDI-DI: 3770011095STRAP_94
Reference / catalog number: S4U - ROSE - T1
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: Orthèse amovible en silicone. Immobilisation en syndactylie des doigts ou des orteils, en cas d'entorse, de luxation, de contusion ou de fracture en fin de consolidation. Reprise sportive.
Additional information URL: https://strap4u.com/accueil/strap4u/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060603FINGERS ORTHOSES

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

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