Identity
- Trade Name
- ViraChip® Reader EUDAMEDViraChip Reader FDA UDI
- Generic Name
- Microplate digital imaging scanner IVD FDA UDI
- Device Name
- Laboratory Device EUDAMEDViraChip Reader FDA UDI
- Model / Reference
- V-UVCCAM EUDAMEDFDA UDI
- Description
- ViraChip Reader FDA UDI
Identifiers
- Catalog Number
- V-UVCCAM FDA UDI
- Primary DI / UDI-DI
- EVIRUVCCAM1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EVIRLaboratoryDeviceFP EUDAMED
- Direct Marketing DI
- EVIRUVCCAM1 EUDAMED
- FDA Product Code
- JQT FDA UDI
- EMDN Code
- W02050107 MICRO-ARRAY SCANNERS EUDAMED
- GMDN Term
- Microplate digital imaging scanner IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2400 FDA UDI
- Market of Registration
- Germany 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ViraChip® Reader by Viramed Biotech AG — 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 | ++EVIRLaboratoryDeviceFP | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Viramed Biotech AG
- EUDAMED SRN
- DE-MF-000020368
Sources (2)
- EUDAMED 6289b2ab-e201-44f9-9a1e-b6f3d9692997 61 fields · synced Jun 18, 2026
- FDA UDI 2eeff272-3052-44f2-b91e-38ab6a3001f4 35 fields · synced May 30, 2026