No Certificate Found

Snapshot 2026-10-09 · Link to EUDAMED

Opal

UDI-DI 04719961300048Basic UDI-DI 471996130OPALHK4

Class I · MDR · Inti Taiwan, Inc.

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Identification

Model: OPAL H1
EMDN: Z12080202
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-09 · Link to EUDAMED

Manufacturer

Inti Taiwan, Inc.

SRN TW-MF-000048831

TW · Zhubei City, Hsinchu County

manufacturer

Authorised representative: Luana Med. B.V. (NL-AR-000002750)

Related UDI-DIs

OPAL 04719961300017

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/opal-0048 · UDI page: /udi/04719961300048

All devices from Inti Taiwan, Inc.

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