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Non-contact tonometer with pachymeter
EUDAMEDClass IIa (EU MDR)
Ref TOP-1000Model TonoVue-P
Identity
- Trade Name
- Non-contact tonometer with pachymeter EUDAMED
- Device Name
- Non-contact Tonometer EUDAMED
- Model / Reference
- TonoVue-P EUDAMEDTOP-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876420183 EUDAMED
- Basic UDI-DI
- 471987642TONOMETERGB EUDAMED
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Non-contact tonometer with pachymeter by Crystalvue Medical Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987642TONOMETERGB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Crystalvue Medical Corporation
- EUDAMED SRN
- TW-MF-000018351
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 5fc55c10-57cf-4f12-b9d3-e8605ac416f8 61 fields · synced Jun 19, 2026