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master diagnóstica
EUDAMEDFDA UDIClass A (EU MDR)
Ref VIT-VS42BCModel VIT-VS42
by Vitro, S.a.
Identity
- Trade Name
- master diagnóstica EUDAMEDNeoPATH Pro FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- VitroStainer 42 / NeoPATH Pro EUDAMED
- Model / Reference
- VIT-VS42 EUDAMEDVIT-VS42BC EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435804518970 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435421200571Y8 EUDAMED
- Direct Marketing DI
- 08435804518970 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
master diagnóstica by Vitro, S.a. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8435421200571Y8 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Vitro, S.a.
- EUDAMED SRN
- ES-MF-000001498
Sources (2)
- EUDAMED e0924a27-eba7-4e2e-84d0-676ed00656d7 61 fields · synced Jul 9, 2026
- FDA UDI d0e5cc9c-0de8-4547-85cb-d11f69f63ce4 32 fields · synced May 30, 2026