Identity
- Trade Name
- Pupilometer EUDAMEDYEASN FDA UDI
- Generic Name
- Pupillometer, manual FDA UDI
- Device Name
- Pupilometer EUDAMED
- Model / Reference
- HX-400 EUDAMEDFDA UDIHX4/1 EUDAMEDHX4/3 EUDAMED
Identifiers
- Catalog Number
- HX4/1 FDA UDI
- Primary DI / UDI-DI
- 06971922134026 EUDAMEDFDA UDI06971922134033 EUDAMED
- Basic UDI-DI
- 697192213400HW EUDAMED
- Direct Marketing DI
- 06971922134026 EUDAMED06971922134033 EUDAMED
- FDA Product Code
- HLH FDA UDI
- EMDN Code
- Z12129099 VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER EUDAMEDZ12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Pupillometer, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1700 FDA UDI
- Market of Registration
- Germany EUDAMEDItaly 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pupilometer 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 | 697192213400HW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (3)
- EUDAMED 1d7a210c-a014-432f-b9fc-66d02549e92c 61 fields · synced Jul 12, 2026
- EUDAMED 07ae8174-0394-44ec-9474-e358e0e2f790 61 fields · synced May 18, 2026
- FDA UDI ca965377-a26d-4072-bc27-881e9d1bcb77 33 fields · synced May 30, 2026