Identity
- Trade Name
- RUV800 WD175 EUDAMEDFDA UDI
- Generic Name
- Ophthalmic slit lamp, surgical FDA UDI
- Device Name
- RUV800 EUDAMEDRUV800 WD175 - Accessory for Leica surgical operating microscope systems FDA UDI
- Model / Reference
- RUV800 EUDAMED10448555 EUDAMED000000000010448555 FDA UDI
- Description
- RUV800 WD175 - Accessory for Leica surgical operating microscope systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003567717 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300035RUV800GS EUDAMED
- FDA Product Code
- HRM FDA UDI
- EMDN Code
- Z1201118099 INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Ophthalmic slit lamp, surgical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Ruv800 Wd175 by Leica Microsystems (schweiz) Ag — Class I — 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 | 76300035RUV800GS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 302239b0-0375-4b52-a519-9fb0251c1f81 61 fields · synced Jul 31, 2026
- FDA UDI fcde13e3-6530-470d-8f13-c0957bb7ad75 36 fields · synced May 30, 2026