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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

Roeko Abrasive Strip — Class I MDR by Polydentia SA

MD Atlas
Polydentia SA

EUDAMED last updated this device on Nov 16, 2021

Roeko Abrasive Strip

++E299ROEKOPOLISHABRASIX6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Polydentia SA
UDI-DI code: +E2995600600
Reference / catalog number: 560060

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Manufacturer information

Organization name: Polydentia SA
SRN: CH-MF-000008779
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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.

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: Roeko Abrasive Strip
UDI-DI code: +E2995600600
Basic UDI-DI: ++E299ROEKOPOLISHABRASIX6
Reference / catalog number: 560060
Issuing entity: HIBCC

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: Aluminium oxyde abrasive
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 60 MU43

EMDN nomenclature code(s)

Q01010403DENTAL ABRASIVE AND POLISHING MATERIALS

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