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master diagnóstica
EUDAMEDFDA UDIClass A (EU MDR)
Ref MAD-HDH3-100VS
by Vitro, S.a.
Identity
- Trade Name
- master diagnóstica EUDAMEDContrast Hematolxylin HDH3 FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Contrast Hematoxylin HDH3 EUDAMED
- Model / Reference
- MAD-HDH3-100VS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435421273498 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435421200579YQ EUDAMED
- Direct Marketing DI
- 08435421273498 EUDAMED
- FDA Product Code
- HYJ FDA UDI
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 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
Yes
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 | 8435421200579YQ | 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 3aa7714d-a47a-4af0-bb96-df1361a12bbe 61 fields · synced Oct 6, 2026
- FDA UDI 7f79d8fe-2971-42b9-a64d-c1c135c47f72 32 fields · synced May 30, 2026