FDA UDI
In Commercial Distribution
🇺🇸 United States
MOPTIM
DI: 06972039971085
·
Model: easyCam
·
Shenzhen CERTAINN Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MOPTIM
- Primary DI
- 06972039971085
- Version / Model
- easyCam
- Company Name
- Shenzhen CERTAINN Technology Co., Ltd.
- Labeler DUNS
- 526992561
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 1
- Public Version Date
- 2025-07-08
- Public Version Status
- New
- Public Device Record Key
- 3a831d20-d9f4-4e9d-a158-21c9ba5cf51c
Device Description
easyCam slit lamp digital module is an upgrade adapter for five-step magnification slit lamps available on the market. It offers three transmission modes: USB, HDMI, and Wi-Fi. Equipped with independent left right detector, it allows for more intuitive and clearer observation of pa-tients' eye images, with dynamic synchronized image display for easy viewing and saving. easyCam uses an HD camera and lens to capture images of the patient's ocular tissues. The software enables photo and video recording and data saving.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46601 | Microscope video camera | An electro-optical device (e.g., with an image sensor chip) designed to convert visual images from a light microscope into digital video (digital conversion) for subsequent electronic display/storage. The device may include an appropriate adaptor for microscope attachment and may include audio recording capabilities. It may be attached to laboratory and/or surgical microscopes to document laboratory examinations and surgical procedures, respectively. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06972039971085 | GS1 |