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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

RH11D — Class I MDR by ORTHOSOFT

MD Atlas
ORTHOSOFT

EUDAMED last updated this device on Mar 4, 2025

RH11D

37602703434010774567J

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTHOSOFT
UDI-DI code: 03760270340332
Reference / catalog number: RH11D

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Manufacturer information

Organization name: ORTHOSOFT
SRN: FR-MF-000000216
Manufacturer status: Active

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: not provided
UDI-DI code: 03760270340332
Basic UDI-DI: 37602703434010774567J
Reference / catalog number: RH11D
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060606HAND 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

Related devices

CA11X37602703434010484836TOn the market CA12X37602703434010484836TOn the market CU11X37602703434010484846VOn the market EP11X3760270343401077455BOn the market FL12D37602703434010449376HOn 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.