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Retinometer SK-6500B
EUDAMEDClass I (EU MDR)
Ref 04Model Retinomter SK-6500A,SK-6500B
Identity
- Trade Name
- Retinometer SK-6500B EUDAMED
- Device Name
- Retinomter EUDAMED
- Model / Reference
- Retinomter SK-6500A,SK-6500B EUDAMED04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973211071357 EUDAMED
- Basic UDI-DI
- 69732110709RE9E EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Retinometer SK-6500B by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69732110709RE9E | Class I | Active |
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Manufacturer
- Manufacturer
- ChongQing SunKingdom Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000014351
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d1cf42f8-fe26-449c-a895-d3145eeb51c7 61 fields · synced Oct 6, 2026