Identity
- Trade Name
- Digital Refractor FDA UDI
- Generic Name
- Phoropter, manual FDA UDI
- Device Name
- To check the refractive state of human eye. FDA UDI
- Model / Reference
- YPA-2100 FDA UDI
- Description
- To check the refractive state of human eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971922130073 FDA UDI
- FDA Product Code
- HKN FDA UDI
- GMDN Term
- Phoropter, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1770 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Digital Refractor by Chongqing Yeasn Science & Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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
- Chongqing Yeasn Science & Technology Co., Ltd.
Sources (2)
- FDA UDI 2996a9b9-7a11-4f4a-940a-c52b946193cb 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026