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HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST
EUDAMEDClass B (EU MDR)
Ref VCM103-PLModel VCM103
by Vircell, S.L
Identity
- Trade Name
- HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST EUDAMED
- Model / Reference
- VCM103 EUDAMEDVCM103-PL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436610290357 EUDAMED08436610290104 EUDAMED
- Basic UDI-DI
- 843661029VCM10301LA EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST by Vircell, S.L — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 843661029VCM10301LA | Class B | Active |
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Manufacturer
- Manufacturer
- Vircell, S.L
- EUDAMED SRN
- ES-MF-000004099
Sources (2)
- EUDAMED 46a842b1-fc6e-4159-ad49-85f2e4c1bdd3 61 fields · synced Sep 18, 2026
- EUDAMED 94d5da4c-d9ed-4a83-a385-ebcf1070501f 61 fields · synced May 18, 2026