Identity
- Trade Name
- M822 - Optics Carrier EUDAMEDM822 Optics Carrier FDA UDI
- Generic Name
- Ophthalmic slit lamp, surgical FDA UDI
- Device Name
- M822 EUDAMEDM822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40 FDA UDI
- Model / Reference
- M822 EUDAMED10448587 EUDAMED000000000010448587 FDA UDI
- Description
- M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003568707 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300035M822DL EUDAMED
- FDA Product Code
- HRM FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES 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
M822 - Optics Carrier 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 | 76300035M822DL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Microsystems (Schweiz) AG
- EUDAMED SRN
- CH-MF-000021185
- Authorised Representative
- Leica Microsystems CMS GmbH DE-AR-000021052
Sources (2)
- EUDAMED 46224656-6330-452a-a2f1-d0122ad8ec8e 61 fields · synced Jul 13, 2026
- FDA UDI 981abff1-8f17-4b4c-9e6c-acda219f67e2 36 fields · synced May 30, 2026