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FL560 for M530
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 10448795Model FL560 for M530
Identity
- Trade Name
- FL560 for M530 EUDAMEDLeica FL560 for M530 FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Device Name
- FL560 for M530 EUDAMED
- Model / Reference
- FL560 for M530 EUDAMED10448795 EUDAMED000000000010448795 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003579475 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300035FL5607Z EUDAMED
- FDA Product Code
- IZI FDA UDI
- EMDN Code
- Z12011199 INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER EUDAMED
- GMDN Term
- Surgical microscope fluorescent angiography system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1600 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
FL560 for M530 by Leica Microsystems (schweiz) Ag — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170239 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 76300035FL5607Z | 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 (3)
- EUDAMED 8c56030c-bceb-4f9f-a869-79b4c3d88ffe 61 fields · synced Jul 19, 2026
- FDA UDI a16923b8-9977-4a00-a8fa-e6b425b9951b 35 fields · synced May 30, 2026
- FDA 510(k) K170239 1 fields · synced May 18, 2026