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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

R607 CE — Class I MDR by Oscimed SA

MD Atlas
Oscimed SA

EUDAMED last updated this device on Aug 31, 2023

R607 CE

764010492BACKAPPLICATOR8X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oscimed SA
UDI-DI code: 07640104926085
Reference / catalog number: R607 CE

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Manufacturer information

Organization name: Oscimed SA
SRN: CH-MF-000009605
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.
CW999
Patient unique utilisation multiple

Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07640104926085
Basic UDI-DI: 764010492BACKAPPLICATOR8X
Reference / catalog number: R607 CE
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: This ergonomic device has a long handle (37 cm) so you can reach inaccessible areas such as the back. Its accessories provide a pleasant massage. Roll easy makes applying even the greasiest creams cleanly and economically.
Additional information URL: https://www.oscimedsa.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - 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

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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.