Identity
- Trade Name
- M320 LW12 EUDAMEDFDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- M320 EUDAMEDWall mount LW12 for M320 - for Leica surgical operating microscope system: M320 LW12 FDA UDI
- Model / Reference
- M320 EUDAMED10448574 EUDAMED000000000010448574 FDA UDI
- Description
- Wall mount LW12 for M320 - for Leica surgical operating microscope system: M320 LW12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003566536 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300035M320CP EUDAMED
- FDA Product Code
- EPT FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- General-purpose surgical microscope 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
M320 Lw12 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 | 76300035M320CP | 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 e0fb4bcc-3fbf-4b77-81c4-0c3e2f11ec67 61 fields · synced Aug 2, 2026
- FDA UDI 241d6f58-0221-458a-a7bc-ccb323106911 36 fields · synced May 30, 2026