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Ophtalmology Instruments For Evaluation And Diagnosis - Others
EUDAMEDClass I (EU MDR)
Ref HX4/4Model HX-400Ref HX4/13
Identity
- Trade Name
- OPHTALMOLOGY INSTRUMENTS FOR EVALUATION AND DIAGNOSIS - OTHERS EUDAMED
- Device Name
- Pupilometer EUDAMED
- Model / Reference
- HX-400 EUDAMEDHX4/4 EUDAMEDHX4/13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971922134040 EUDAMED06971922134095 EUDAMED
- Basic UDI-DI
- 697192213400HW EUDAMED
- Direct Marketing DI
- 06971922134040 EUDAMED06971922134095 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Ophtalmology Instruments For Evaluation And Diagnosis - Others by Chongqing Yeasn Science - Technology Co., Ltd — Class I — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697192213400HW | Class I | Active |
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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 (2)
- EUDAMED dfd665ec-c09b-4b64-a419-c641bf4e98b2 61 fields · synced Jul 19, 2026
- EUDAMED d25dbba9-2fb3-433f-81ef-0b5918b4014d 61 fields · synced May 18, 2026