Identity
- Trade Name
- Vision Tester EUDAMEDYEASN FDA UDI
- Generic Name
- Phoropter, manual FDA UDI
- Device Name
- Vision Tester EUDAMEDThis instrument is intended to be used for performing subjective refraction eye examinations. FDA UDI
- Model / Reference
- MPH150 EUDAMEDFDA UDI
- Description
- This instrument is intended to be used for performing subjective refraction eye examinations. FDA UDI
Identifiers
- Catalog Number
- MPH150 FDA UDI
- Primary DI / UDI-DI
- 06971922132558 EUDAMEDFDA UDI
- Basic UDI-DI
- 697192213255898 EUDAMED
- Direct Marketing DI
- 06971922132558 EUDAMED
- FDA Product Code
- HKN FDA UDI
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
- GMDN Term
- Phoropter, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1770 FDA UDI
- Market of Registration
- France 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
Yes
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
Yes
FDA UDI
Vision Tester by Chongqing Yeasn Science - Technology 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 | 697192213255898 | 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
- Chongqing Yeasn Science - Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000012019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 3ac64552-1376-4be7-a3e2-b385ca9cbeca 61 fields · synced Jun 1, 2026
- FDA UDI 81e7cc63-c7cf-42ac-af94-b60de78debce 34 fields · synced May 30, 2026