Identity
- Trade Name
- TRIAL FRAME EUDAMEDINAMI FDA UDI
- Generic Name
- Trial lens frame FDA UDI
- Device Name
- OPHTHALMIC DEVICES – OTHER EUDAMEDUNIVERSAL TRIAL FRAME FDA UDI
- Model / Reference
- K-0391 EUDAMEDFDA UDI
- Description
- UNIVERSAL TRIAL FRAME FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547451081722 EUDAMEDFDA UDI
- Basic UDI-DI
- 454745100005A8 EUDAMED
- FDA Product Code
- HPA FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Trial lens frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1415 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Trial Frame by Inami & Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 454745100005A8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inami & Co., Ltd.
- EUDAMED SRN
- JP-MF-000040062
- Authorised Representative
- WMDE B.V. NL-AR-000002062
Sources (2)
- EUDAMED 1f056d49-1aa6-4bd7-8204-642519418c76 61 fields · synced Jul 26, 2026
- FDA UDI 46c58a8d-9a49-415b-a666-224727b98ef8 33 fields · synced May 30, 2026