Identity
- Trade Name
- WRI-1 FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- Wide-field Retinal Imager EUDAMEDThe device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye. FDA UDI
- Model / Reference
- WRI-1 EUDAMEDWRI-01 EUDAMED01 FDA UDI
- Description
- The device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628678036017 EUDAMEDFDA UDI
- Basic UDI-DI
- 628678036WRI-01P6 EUDAMED
- FDA Product Code
- PJZ FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
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
Yes
FDA UDI
Wide-field Retinal Imager by Cellview Imaging Inc. — 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 | 628678036WRI-01P6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cellview Imaging Inc.
- EUDAMED SRN
- CA-MF-000037737
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED ac0648dd-b8ac-4ee0-b82c-c2e90db14f3f 61 fields · synced Jun 18, 2026
- FDA UDI 00d5dfa9-dd80-4840-83a8-6f9a7be117bd 33 fields · synced May 30, 2026