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OP02

by Borch Textile Group A/S 7 variants

Ref OP02

OP02 is a Class I device made by Borch Textile Group A/S, registered in EUDAMED on 22 Aug 2024 (Basic UDI-DI 5715765OP2H6), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5715765OP2H6 Basic UDI-DI Date22 Aug 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
OP02
Model / reference
OP02
Primary DI / UDI-DI
05715765003979, 05715765006987, 05715765006376, 05715765006512, 05715765006451, 05715765006291, 05715765007052, 05715765004402, 05715765005508, 05715765006581, 05715765004082, 05715765004020, 05715765004594, 05715765006499, 05715765004129, 05715765003993, 05715765006741, 05715765005478, 05715765006642, 05715765005485, 05715765005492, 05715765004273, 05715765006550, 05715765004280, 05715765006703, 05715765006697, 05715765006352, 05715765005515, 05715765004488, 05715765004075, 05715765006475, 05715765004464, 05715765006345, 05715765004648, 05715765004143, 05715765004570, 05715765004297, 05715765006420, 05715765006406, 05715765006796, 05715765005461, 05715765004549, 05715765006598, 05715765004037, 05715765003948, 05715765004303, 05715765004068, 05715765007021, 05715765005454, 05715765006543, 05715765004174
Basic UDI-DI
5715765OP2H6
EMDN code
T0299 Protection drapes and garments - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000041570

Similar devices in this category

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Properties

  • Reprocessed single-use device
Other properties (13, all answered No)