Identity
- Trade Name
- TRIAL FRAME EUDAMED
- Device Name
- OPHTHALMIC DEVICES – OTHER EUDAMED
- Model / Reference
- K-0391 EUDAMEDK-0391-V EUDAMEDK-0391-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547451321033 EUDAMED04547451321019 EUDAMED
- Basic UDI-DI
- 454745100005A8 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Trial Frame by Inami & Co., Ltd. — 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 | 454745100005A8 | Class I | Active |
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Manufacturer
- Manufacturer
- Inami & Co., Ltd.
- EUDAMED SRN
- JP-MF-000040062
- Authorised Representative
- WMDE B.V. NL-AR-000002062
Sources (2)
- EUDAMED 5b74b6dc-b046-457b-8589-ad5f4b0fbace 61 fields · synced Jul 30, 2026
- EUDAMED cc2ea854-e074-43cf-9dce-99b235e18882 61 fields · synced May 18, 2026