Identity
- Trade Name
- SPECULAR MICROSCOPE SP-1P EUDAMED
- Device Name
- SPECULAR MICROSCOPE SP-1P EUDAMEDSPECULAR MICROSCOPE EUDAMED
- Model / Reference
- SP-1P EUDAMED419049700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562123286960 EUDAMED04571130283466 EUDAMED
- Basic UDI-DI
- B-04562123286960 EUDAMED4560126260070UC EUDAMED
- EMDN Code
- Z12120110 CORNEAL CONFOCAL MICROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Netherlands 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
Specular Microscope Sp-1p by Topcon Corporation — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04562123286960 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04562123286960 | Class I | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (2)
- EUDAMED 9733200b-07c6-4857-ac4f-5ecf2c87ba38 61 fields · synced Jul 30, 2026
- EUDAMED e20dbe89-6095-4ff4-8c85-44d8678c2c2c 61 fields · synced May 18, 2026