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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

STRAP4U-URIEL-BLACK S/M — Class I MDR by CREATION XXI

MD Atlas
CREATION XXI

EUDAMED last updated this device on Dec 22, 2022

STRAP4U-URIEL-BLACK S/M

3770011095STRAP_01ZW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CREATION XXI
UDI-DI code: 72970461300650
Reference / catalog number: STRAP4U - URIEL - BK -S/M

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Manufacturer information

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

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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-URIEL-BLACK S/M
UDI-DI code: 72970461300650
Basic UDI-DI: 3770011095STRAP_01ZW
Reference / catalog number: STRAP4U - URIEL - BK -S/M
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. [FR]
Additional information URL: https://strap4u.com/en/home/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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.