Identity
- Trade Name
- UNIVERSAL TRIAL FRAME EUDAMEDInami Ophthalmic Instruments FDA UDI
- Generic Name
- Trial lens frame FDA UDI
- Device Name
- OPHTHALMIC DEVICES – OTHER EUDAMEDInami Universal Light Weight Trial Frame FDA UDI
- Model / Reference
- K-0391T EUDAMEDFDA UDI
- Description
- Inami Universal Light Weight Trial Frame FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547451333883 EUDAMEDFDA UDI
- Basic UDI-DI
- 454745100004A6 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
Universal 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 | 454745100004A6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 a57b0fc1-dec0-4f3d-9c97-e4e2bc20a6c7 61 fields · synced Jun 18, 2026
- FDA UDI a7bdc07c-7668-4363-8efd-b7f475a0e904 33 fields · synced May 30, 2026