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D-Kat R-Type (disposable Prism)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2414-P-2041
by Keeler Ltd
Identity
- Trade Name
- D-KAT R-TYPE (DISPOSABLE PRISM) EUDAMEDFDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- D-KAT R-TYPE (DISPOSABLE PRISM) EUDAMED
- Model / Reference
- 2414-P-2041 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272716901 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055272716901 EUDAMED
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
- GMDN Term
- Ophthalmic tonometer, battery-operated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Netherlands 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
D-Kat R-Type (disposable Prism) by Keeler Ltd — Class IIa — 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-05055272716901 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 a3caffd5-4096-4a4a-9390-a6a753d55d56 61 fields · synced Jun 18, 2026
- FDA UDI 986d3137-f372-4fbf-8e21-c64b617c8c95 32 fields · synced May 30, 2026