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Applanation Tonometer
EUDAMEDClass I (EU MDR)
Ref D130Model DEM650Ref T173Model T170,TAT-80R
Identity
- Trade Name
- Applanation Tonometer EUDAMED
- Device Name
- Dry Eye Module EUDAMEDApplanation Tonometer EUDAMED
- Model / Reference
- DEM650 EUDAMEDD130 EUDAMEDT170,TAT-80R EUDAMEDT173 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945087500019 EUDAMED06945087500224 EUDAMED
- Basic UDI-DI
- 69450875DryEyeModuleAS EUDAMED69450875TonometersV5 EUDAMED
- Direct Marketing DI
- 06945087500019 EUDAMED06945087500224 EUDAMED
- EMDN Code
- Z12129099 VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER EUDAMEDZ12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Applanation Tonometer by Shanghai Mediworks Precision Instruments 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 | 69450875DryEyeModuleAS | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Mediworks Precision Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000004251
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 2e68ab5f-dbf7-49e5-8588-2e7e95d351c7 61 fields · synced Jul 16, 2026
- EUDAMED 2655803c-f590-4f0f-b9e1-f8b050ee8a1c 61 fields · synced May 18, 2026