Identity
- Trade Name
- OPAL EUDAMED
- Device Name
- “Inti” Oocyte Holding Device (Non-Sterile) EUDAMED
- Model / Reference
- OPAL H1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961300017 EUDAMED
- Basic UDI-DI
- 471996130OPALHK4 EUDAMED
- Direct Marketing DI
- 04719961300017 EUDAMED
- EMDN Code
- Z12080202 OOCYTE ASPIRATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Opal by Inti Taiwan, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471996130OPALHK4 | Class I | Active |
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Manufacturer
- Manufacturer
- Inti Taiwan, Inc.
- EUDAMED SRN
- TW-MF-000048831
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 04bb1c15-68ad-48a3-bed0-6acb5e5c52f0 61 fields · synced Jun 20, 2026