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master diagnóstica
EUDAMEDFDA UDIClass A (EU MDR)
Ref MAD-004080VS
by Vitro, S.a.
Identity
- Trade Name
- master diagnóstica EUDAMEDDewax Solution FDA UDI
- Generic Name
- Dewaxing solution IVD FDA UDI
- Device Name
- Dewax Solution EUDAMED
- Model / Reference
- MAD-004080VS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435421272934 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435421200574YE EUDAMED
- Direct Marketing DI
- 08435421272934 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Dewaxing solution IVD 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
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 | 8435421200574YE | 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 ef75f29d-1c92-42c6-b39d-32ac9ad03f4b 61 fields · synced Jun 18, 2026
- FDA UDI 42e945d6-3dbe-4fb1-9d3c-a7c04fca2e5a 32 fields · synced May 30, 2026