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Glow800
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 10449156Model GLOW800510(k) K181537
Identity
- Trade Name
- GLOW800 EUDAMEDFDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Device Name
- GLOW800 EUDAMEDGLOW800 - Accessory for Leica surgical operating microscope systems FDA UDI
- Model / Reference
- GLOW800 EUDAMED10449156 EUDAMED000000000010449156 FDA UDI
- Description
- GLOW800 - Accessory for Leica surgical operating microscope systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630802402615 EUDAMEDFDA UDI
- Basic UDI-DI
- 76308024GLOW800L5 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
Glow800 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 | K181537 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 76308024GLOW800L5 | 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 0510506b-2528-4c29-90d1-3d73f8012575 85 fields · synced Jun 18, 2026
- FDA UDI f6bd6751-7a76-4c90-b913-56e60ff6c4e3 36 fields · synced May 29, 2026
- FDA 510(k) K181537 1 fields · synced May 19, 2026