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Ophthalmic Ultrasound Examination Instrument SK-3000A
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 04Model SK-3000A,SK-2000AP
Identity
- Trade Name
- Ophthalmic Ultrasound Examination Instrument SK-3000A EUDAMED
- Device Name
- Ophthalmic Ultrasound Examination Instrument EUDAMED
- Model / Reference
- SK-3000A,SK-2000AP EUDAMED04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973211071296 EUDAMED
- Basic UDI-DI
- 69732110705OU9H EUDAMED
- EMDN Code
- L1705,Z11049092 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ophthalmic Ultrasound Examination Instrument SK-3000A by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222787 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69732110705OU9H | Class IIa | 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 (2)
- EUDAMED 1da6abfa-9d1f-4ec1-a171-fb65bd244f9e 61 fields · synced Oct 9, 2026
- FDA 510(k) K222787 1 fields · synced May 18, 2026