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Non-contact Tonometer
EUDAMEDClass IIa (EU MDR)
Ref Z12120122Model SK-5000A, SK-5000B
Identity
- Trade Name
- Non-contact Tonometer EUDAMED
- Device Name
- Non-contact Tonometer EUDAMED
- Model / Reference
- SK-5000A, SK-5000B EUDAMEDZ12120122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973211071333 EUDAMED
- Basic UDI-DI
- 69732110708NT9T EUDAMED
- Direct Marketing DI
- 06973211071333 EUDAMED
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Non-contact Tonometer by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class IIa — 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 | 69732110708NT9T | 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 (1)
- EUDAMED fe5db7a0-5992-4d83-839f-d049f21a7c10 61 fields · synced Oct 8, 2026