master diagnóstica
EUDAMEDFDA UDIClass A (EU MDR)
by Vitro, S.a.
Identity
- Trade Name
- master diagnóstica EUDAMEDMaster Polymer Plus Detection System (Peroxidase) FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, reagent FDA UDI
- Device Name
- Master Polymer Plus Detection System (Peroxidase) EUDAMED
- Model / Reference
- MAD-000237QP-100/V EUDAMEDMAD-000237QKVSBC EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435421290938 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435421200455Y5 EUDAMED
- Direct Marketing DI
- 08435421290938 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
master diagnóstica by Vitro, S.a. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8435421200455Y5 | 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 b5b327a6-1605-4f0f-a565-8a5cd96e603e 61 fields · synced Jun 18, 2026
- FDA UDI 037a97a3-0149-4fba-abc4-602b6751511b 32 fields · synced May 30, 2026