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EUDAMED last updated this device on Mar 28, 2025
5715765OP1H4OP01 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Borch Textile Group A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
057157650008005715765OP1H4OP01(01)05715765000800
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
T0299PROTECTION DRAPES AND GARMENTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Aug 22, 2024 | Still on market |
| Iceland | Aug 22, 2024 | Still on market |
| Norway | Aug 22, 2024 | Still on market |
| Sweden | Aug 22, 2024 | Still on market |
DK-MF-000041570No 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.