← Back to catalogue
At-1
EUDAMEDFDA 510(k)FDA UDIClass I (EU MDR)
Ref J202111-ENModel AT-2510(k) K172728Ref AT-1Model AT-1、AT-2
by Takagi seiko
Identity
- Trade Name
- AT-1 EUDAMEDApplanation Tonometer AT-1 EUDAMEDTAKAGI FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Applanation Tonometer EUDAMED
- Model / Reference
- AT-2 EUDAMEDJ202111-EN EUDAMEDAT-1 EUDAMEDFDA UDIAT-1、AT-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560323648564 EUDAMEDFDA UDI
- Basic UDI-DI
- 4560323640012UP EUDAMEDB-04560323648564 EUDAMED
- 510(k) Number
- FDA Product Code
- HKY FDA 510(k)FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic tonometer, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMEDSpain EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
At-1 by Takagi seiko — Class I — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172728 | Class I | Active |
| EUDAMED | European Union | CE/MDD | 4560323640012UP | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4560323640012UP | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Takagi seiko
- EUDAMED SRN
- JP-MF-000008791
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (5)
- EUDAMED 787ef4bc-86c3-467c-a7e9-f3e7266acd23 61 fields · synced Jul 31, 2026
- FDA 510(k) K172728 24 fields · synced May 18, 2026
- FDA UDI a8571576-c61b-4070-90bc-eb926c54f514 33 fields · synced May 30, 2026
- EUDAMED 24510075-4f44-4214-81fe-1548aec97bf4 61 fields · synced Jul 18, 2026
- EUDAMED 4a004ee5-90ee-4c6f-88b7-fde442ed7632 61 fields · synced Jul 31, 2026