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Applanation Tonometer
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref TAT-80RModel T170,TAT-80R
Identity
- Trade Name
- Applanation Tonometer EUDAMEDMediworks FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Applanation Tonometer EUDAMED
- Model / Reference
- T170,TAT-80R EUDAMEDTAT-80R EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087580004 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450875TonometersV5 EUDAMED
- Direct Marketing DI
- 06945087580004 EUDAMED
- 510(k) Number
- K142263 FDA UDI
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
- GMDN Term
- Ophthalmic tonometer, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Applanation Tonometer by Shanghai Mediworks Precision Instruments Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K142263 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69450875TonometersV5 | Class IIa | 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 (3)
- EUDAMED 6d38b657-854a-4d15-8634-910a0004665b 61 fields · synced Jun 19, 2026
- FDA UDI 625c706c-04bc-4ab3-9f78-be83fa99bee2 33 fields · synced May 30, 2026
- FDA 510(k) K142263 1 fields · synced May 18, 2026