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Opal

by Inti Taiwan, Inc. 2 variants

Ref Opal H2Model OPAL H1

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471996130OPALHK4 Basic UDI-DI 04719961300048UDI-DIDate16 Sep 2025RegisteredStatusActive

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  • Withdrawn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
“Inti” Oocyte Holding Device (Non-Sterile)
Model / Reference
OPAL H1, Opal H2
Primary DI / UDI-DI
04719961300048
Basic UDI-DI
471996130OPALHK4
Direct Marketing DI
04719961300048
EMDN Code
Z12080202 Oocyte aspiration equipment
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
TW-MF-000048831
Authorised representative
Luana Med. B.V. NL-AR-000002750

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