Identity
- Trade Name
- Applanation Tonometer SL-TM EUDAMED
- Device Name
- Applanation Tonometer SL-TM EUDAMED
- Model / Reference
- B-45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571260230705 EUDAMED
- Basic UDI-DI
- 4571260230038S EUDAMED
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Applanation Tonometer SL-TM by Ohira Co., Ltd. — Class I — 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 | 4571260230038S | Class I | Active |
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Manufacturer
- Manufacturer
- Ohira Co., Ltd.
- EUDAMED SRN
- JP-MF-000004195
- Authorised Representative
- Rexxam Co., Ltd. Netherlands Office NL-AR-000002643
Sources (1)
- EUDAMED 1e7284e7-ad5a-42a8-a369-142fe7dd1681 61 fields · synced Oct 5, 2026