← Back to catalogue
Mycobacterium Realtime Pcr Kit
EUDAMEDClass C (EU MDR)
Ref RTPCR016-LPDModel RTPCR016
by Vircell, S.L
Identity
- Trade Name
- MYCOBACTERIUM REALTIME PCR KIT EUDAMED
- Model / Reference
- RTPCR016 EUDAMEDRTPCR016-LPD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436040329436 EUDAMED
- Basic UDI-DI
- 843604032RTPCR01601W4 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Mycobacterium Realtime Pcr Kit by Vircell, S.L — Class C — 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 | 843604032RTPCR01601W4 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vircell, S.L
- EUDAMED SRN
- ES-MF-000004099
Sources (1)
- EUDAMED 50c6282b-1b06-4bb9-aa41-f8d88f036a99 61 fields · synced Jul 24, 2026