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Fundus Camera SK-660A
EUDAMEDClass I (EU MDR)
Ref 04Model SK-650A,SK-660A,SK-650B,SK-680A
Identity
- Trade Name
- Fundus Camera SK-660A EUDAMED
- Device Name
- Fundus Camera EUDAMED
- Model / Reference
- SK-650A,SK-660A,SK-650B,SK-680A EUDAMED04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973211071258 EUDAMED
- Basic UDI-DI
- 69732110703FC78 EUDAMED
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Fundus Camera SK-660A 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 | 69732110703FC78 | 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 68c07ef4-2c29-4ed3-98a4-e38c218c5b90 61 fields · synced Oct 10, 2026