Identity
- Trade Name
- PROVEO 8 - OCT Ready (CN) EUDAMED
- Device Name
- PROVEO 8 EUDAMED
- Model / Reference
- PROVEO 8 EUDAMED10449199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630802404138 EUDAMED
- Basic UDI-DI
- 76300035PROVEO8RV EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PROVEO 8 - OCT Ready (CN) by Leica Microsystems (schweiz) Ag — 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 | 76300035PROVEO8RV | Class I | Active |
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Manufacturer
- Manufacturer
- Leica Microsystems (Schweiz) AG
- EUDAMED SRN
- CH-MF-000021185
- Authorised Representative
- Leica Microsystems CMS GmbH DE-AR-000021052
Sources (1)
- EUDAMED 0ed8cbb6-937d-43f2-9598-6cd538921caf 61 fields · synced Jun 19, 2026