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00 - Romeo Noir Modifie Velcro

by Medical Z

Ref EC038-111TA-0HM

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 25 Oct 2026. What this means

Overview

Discover the ROMEO NOIR MODIFIE VELCRO medical device, a innovative solution for surgical procedures in orthopedic and reconstructive surgery. This device offers a unique combination of features and benefits, ensuring optimal patient outcomes while maintaining regulatory compliance.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3660381G_ESTYR Basic UDI-DI 03660381044757UDI-DIDate1 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Vêtements de chirurgie plastique
Model / Reference
EC038-111TA-0HM
Primary DI / UDI-DI
03660381044757
Basic UDI-DI
3660381G_ESTYR
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000009342

Other devices from Medical Z

See all devices from Medical Z →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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