Identity
- Trade Name
- GLOW800 EUDAMEDLeica GLOW800 FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Device Name
- GLOW800 EUDAMED
- Model / Reference
- GLOW800 EUDAMED10448962 EUDAMED000000000010448962 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003590401 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 — 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 | 76308024GLOW800L5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 6922a951-bd84-4ea4-873c-19530d65bab0 61 fields · synced Jun 17, 2026
- FDA UDI 9afd9ef1-f8f3-4f45-8e3a-127e98e8f1a9 35 fields · synced May 30, 2026