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Keeler Applanation Tonometer (t-Type)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2414-P-2030
by Keeler Ltd
Identity
- Trade Name
- KEELER APPLANATION TONOMETER (T-TYPE) EUDAMEDKAT T-Type FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- KEELER APPLANATION TONOMETER (T-TYPE) EUDAMED
- Model / Reference
- 2414-P-2030 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272712194 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055272712194 EUDAMED
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
- GMDN Term
- Ophthalmic tonometer, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Poland 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
Keeler Applanation Tonometer (t-Type) by Keeler Ltd — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055272712194 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (2)
- EUDAMED 1d8a31b8-d93e-4103-84d3-ae146f24707b 61 fields · synced May 30, 2026
- FDA UDI ce213745-a193-48e6-b0b7-f687f8f82164 32 fields · synced May 30, 2026