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master diagnóstica
EUDAMEDFDA UDIClass A (EU MDR)
Ref MAD-003931CSVS
by Vitro, S.a.
Identity
- Trade Name
- master diagnóstica EUDAMEDCleaning Solution 10X FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- Cleaning Solution 10X EUDAMED
- Model / Reference
- MAD-003931CSVS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435421272927 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435421200573YC EUDAMED
- Direct Marketing DI
- 08435421272927 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
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 | 8435421200573YC | 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 d90c87bd-5beb-433b-abfc-07b08e2c6544 61 fields · synced Jun 18, 2026
- FDA UDI a6ea44a3-3cb6-4c23-9fa5-85c0d8b654c0 32 fields · synced May 30, 2026