← Back to catalogue
Visiolite Master GT
EUDAMEDFDA UDIClass I (EU MDR)
Ref FF1017Model Visiolite / VT1
by FIM Medical
Identity
- Trade Name
- Visiolite Master GT EUDAMEDVT1 FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Viiolite EUDAMED
- Model / Reference
- Visiolite / VT1 EUDAMEDFF1017 EUDAMEDSoftware FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760253450577 EUDAMEDFDA UDI
- Basic UDI-DI
- 376025345FF1160TL EUDAMED
- 510(k) Number
- K161676 FDA UDI
- FDA Product Code
- BZG FDA UDI
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- France 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Visiolite Master GT by FIM Medical — 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 | 376025345FF1160TL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FIM Medical
- EUDAMED SRN
- FR-MF-000017090
Sources (2)
- EUDAMED a2b3b2c3-39cd-40df-b6f5-bb56f20a986f 61 fields · synced Jun 18, 2026
- FDA UDI 9f062122-61db-4a2c-876a-753bbdf0830e 33 fields · synced May 30, 2026