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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

ORTHOPUS supporter — Class I MDR by ORTHOPUS

MD Atlas
ORTHOPUS

EUDAMED last updated this device on Sep 18, 2023

ORTHOPUS supporter

37700264780204NX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTHOPUS
UDI-DI code: 03770026478004
Reference / catalog number: 0204

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Manufacturer information

Organization name: ORTHOPUS
SRN: FR-MF-000037107
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

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: ORTHOPUS supporter
UDI-DI code: 03770026478004
Basic UDI-DI: 37700264780204NX
Reference / catalog number: 0204
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: https://orthopus.com/wp-content/uploads/2023/03/Manuel-dutilisation-IFU-ORTHOPUS-SUPPORTER-FR-_-v1.1-1.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y241899ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER

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

ORTHOPUS37700264781002NQOn 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.