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OP01

by Borch Textile Group A/S 43 variants

Ref OP01

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5715765OP1H4 Basic UDI-DI Date22 Aug 2024RegisteredStatusActive

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  • Withdrawn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
OP01
Model / Reference
OP01
Primary DI / UDI-DI
05715765003795, 05715765005218, 05715765003092, 05715765004655, 05715765005263, 05715765005546, 05715765005232, 05715765003498
Basic UDI-DI
5715765OP1H4
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000041570

Other devices from Borch Textile Group A/S

See all devices from Borch Textile Group A/S →

Properties

  • Reprocessed

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No