Identity
- Trade Name
- ARveo 8x EUDAMEDFDA UDI
- Generic Name
- Neurosurgical microscope FDA UDI
- Device Name
- ARveo 8x EUDAMEDARveo 8x stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8x FDA UDI
- Model / Reference
- ARveo 8x EUDAMED10449213 EUDAMEDFDA UDI
- Description
- ARveo 8x stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8x FDA UDI
Identifiers
- Catalog Number
- 10449213 FDA UDI
- Primary DI / UDI-DI
- 07630802405906 EUDAMEDFDA UDI
- Basic UDI-DI
- 76308024ARveo8xDN EUDAMED
- FDA Product Code
- EPT FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- Neurosurgical microscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
ARveo 8x by Leica Microsystems (schweiz) Ag — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76308024ARveo8xDN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 01f19434-89b9-4947-9a79-d4f916a73773 61 fields · synced Jun 18, 2026
- FDA UDI 5edcef9d-5374-4420-90a4-bee57e4daead 35 fields · synced May 30, 2026