Identity
- Trade Name
- TonoCare EUDAMED
- Device Name
- TonoCare EUDAMED
- Model / Reference
- 2418-P-2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272718790 EUDAMED
- Basic UDI-DI
- B-05055272718790 EUDAMED
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
TonoCare by Keeler Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055272718790 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (1)
- EUDAMED f3ea9d1d-6f8a-4a0f-bc8c-a76f71ae0265 61 fields · synced Jun 18, 2026