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Fl800 Ult
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 10449023Model FL800 ULT
Identity
- Trade Name
- FL800 ULT EUDAMEDLeica FL800 ULT FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Device Name
- FL800 ULT EUDAMED
- Model / Reference
- FL800 ULT EUDAMED10449023 EUDAMED000000000010449023 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003593587 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300035FL8007W 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 IIa 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
Fl800 Ult by Leica Microsystems (schweiz) Ag — Class IIa — 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 | K080612 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 76300035FL8007W | Class IIa | 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 30027415-f91f-4e69-90d0-c9dce5594f45 61 fields · synced Jul 29, 2026
- FDA UDI a46e8ae3-729f-49fb-8d7c-1a3184bc9638 35 fields · synced May 30, 2026
- FDA 510(k) K080612 1 fields · synced May 18, 2026