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Pneumocystis Jirovecii Realtime Pcr Kit
EUDAMEDClass B (EU MDR)
Ref RTPCR027-LPModel RTPCR027
by Vircell, S.L
Identity
- Trade Name
- PNEUMOCYSTIS JIROVECII REALTIME PCR KIT EUDAMED
- Model / Reference
- RTPCR027 EUDAMEDRTPCR027-LP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436610290180 EUDAMED
- Basic UDI-DI
- 843661029RTPCR027018Y EUDAMED
- EMDN Code
- W0105060499 MYCOLOGY NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Pneumocystis Jirovecii Realtime Pcr Kit 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 | 843661029RTPCR027018Y | Class B | Active |
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Manufacturer
- Manufacturer
- Vircell, S.L
- EUDAMED SRN
- ES-MF-000004099
Sources (1)
- EUDAMED a3387b6c-83cf-46f9-b15b-fca0009f4d71 61 fields · synced Jun 20, 2026