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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

8080754 — Class I MDR by Meyra GmbH

MD Atlas
Meyra GmbH

EUDAMED last updated this device on May 20, 2022

8080754

4032766347458L

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Meyra GmbH
UDI-DI code: 04032766347460
Reference / catalog number: 8080754

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Manufacturer information

Organization name: Meyra GmbH
SRN: DE-MF-000005780
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.

CW010
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: not provided
UDI-DI code: 04032766347460
Basic UDI-DI: 4032766347458L
Reference / catalog number: 8080754
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: Die Finger- bzw. Formschiene dient in erster Linie der Fixierung eines Gelenkes bzw. einer Extremität zu dessen kurz- bis mittelfristigen Ruhigstellung bei Gelenk-, Knochen- und Weichteilverletzungen sowie degenerativen Veränderungen, Instabilität und entzündlichen Prozessen.
Additional information URL: https://kisss-by-meyra.de/ALLdokuarchiv.php?suche=Formschiene
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