Identity
- Trade Name
- AT-2 EUDAMEDTAKAGI FDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- Ophthalmic tonometer, manual EUDAMEDApplanation Tonometer EUDAMED
- Model / Reference
- J202111-EN EUDAMEDAT-2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560323648519 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560323648519 EUDAMED4560323640012UP EUDAMED
- 510(k) Number
- K182491 FDA UDI
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic tonometer, battery-operated FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Northern Ireland EUDAMEDNetherlands 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
Yes
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-2 by Takagi seiko — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04560323648519 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-04560323648519 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Takagi seiko
- EUDAMED SRN
- JP-MF-000008791
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 57adb16e-9770-4ed5-a60e-bcde005b6fa4 61 fields · synced Jun 8, 2026
- EUDAMED 30277d97-9240-4c56-bc22-12eed686efad 61 fields · synced May 17, 2026
- FDA UDI 966bab55-ae01-458a-acb6-6bf99f3f6d64 33 fields · synced May 30, 2026