Skip to content

OP01

by Borch Textile Group A/S EUDAMED

Active European Union

Ref OP01

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
OP01
Model / Reference
OP01
Primary DI / UDI-DI
05715765004891, 05715765002156, 05715765006895, 05715765002590, 05715765006871, 05715765002804, 05715765002873, 05715765002538, 05715765001838, 05715765004938, 05715765003160, 05715765000992, 05715765005584, 05715765001081, 05715765001159, 05715765006062, 05715765006840, 05715765004884, 05715765000244, 05715765002675, 05715765001821, 05715765002569, 05715765002705, 05715765000015, 05715765003337, 05715765000664, 05715765001975, 05715765000169, 05715765001425, 05715765000848, 05715765003535, 05715765000237, 05715765005935, 05715765001203, 05715765003481, 05715765004754, 05715765006000, 05715765001029, 05715765003412, 05715765003627, 05715765001753, 05715765002095, 05715765002774, 05715765000787, 05715765002378, 05715765001098, 05715765007168, 05715765001814, 05715765002965, 05715765005645
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

Show 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