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OP01

by Borch Textile Group A/S Denmark EUDAMED

Ref OP01

EMDN T0299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5715765OP1H4 Basic UDI-DIDate22 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
OP01
Model / Reference
OP01
Primary DI / UDI-DI
05715765006055, 05715765002323, 05715765001715, 05715765005621, 05715765006093, 05715765005836, 05715765006321, 05715765000305
Basic UDI-DI
5715765OP1H4
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (8)

  • EUDAMED a9162ae4-ba34-4c21-b244-8219cfff5a97 61 fields · synced 22 Oct 2026
  • EUDAMED 05715765002323|5715765OP1H4 61 fields · synced 17 May 2026
  • EUDAMED 05715765001715|5715765OP1H4 61 fields · synced 18 May 2026
  • EUDAMED 05715765005621|5715765OP1H4 61 fields · synced 19 May 2026
  • EUDAMED 05715765006093|5715765OP1H4 61 fields · synced 19 May 2026
  • EUDAMED 05715765005836|5715765OP1H4 61 fields · synced 19 May 2026
  • EUDAMED 05715765006321|5715765OP1H4 61 fields · synced 19 May 2026
  • EUDAMED 05715765000305|5715765OP1H4 61 fields · synced 19 May 2026