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Applanation Tonometer SK-R
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 04Model SK-T, SK-R, SK-Q
Identity
- Trade Name
- Applanation Tonometer SK-R EUDAMED
- Device Name
- Applanation Tonometer EUDAMED
- Model / Reference
- SK-T, SK-R, SK-Q EUDAMED04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973211071289 EUDAMED
- Basic UDI-DI
- 69732110704AT7Y EUDAMED
- EMDN Code
- Z12120122 TONOMETERS 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
Applanation Tonometer SK-R by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K191314 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69732110704AT7Y | 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 902f976f-9c9f-4485-ae2c-109e09a7db7f 61 fields · synced Oct 6, 2026
- FDA 510(k) K191314 1 fields · synced May 18, 2026