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master diagnóstica
EUDAMEDFDA UDIClass A (EU MDR)
Ref MAD-011892QEVSBCModel MAD-011892QEVS
by Vitro, S.a.
Identity
- Trade Name
- master diagnóstica EUDAMEDProteinase K (RTU) FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
- Device Name
- Proteinase K (RTU) EUDAMED
- Model / Reference
- MAD-011892QEVS EUDAMEDMAD-011892QEVSBC EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435804522328 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435421200591YE EUDAMED
- Direct Marketing DI
- 08435804522328 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, reagent 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 | 8435421200591YE | 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 978840c1-98b6-4cad-8c9a-ab9283ca17a2 61 fields · synced Jul 9, 2026
- FDA UDI fbf91ef0-5ec4-4642-ba1f-dec0163133f7 32 fields · synced May 30, 2026