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Organization name
UDI-DI code
Reference / catalog number

13616 — Class I MDR by REBOTEC Rehabilitationsm…

MD Atlas
REBOTEC Rehabilitationsmittel GmbH

EUDAMED last updated this device on Mar 8, 2024

13616

4046678_GHGSxx-0003-125KM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: REBOTEC Rehabilitationsmittel GmbH
UDI-DI code: 04046678002638
Reference / catalog number: 13616

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Manufacturer information

Organization name: REBOTEC Rehabilitationsmittel GmbH
SRN: DE-MF-000009447
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 Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04046678002638
Basic UDI-DI: 4046678_GHGSxx-0003-125KM
Reference / catalog number: 13616
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://www.rebotec.de/downloads
Clinical sizes: 125 MU29

EMDN nomenclature code(s)

Y120399WALKING DEVICES, ONE-HANDED OPERATION - 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

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Software identification