← Back to catalogue
VitaPCR SARS-CoV-2 Gen 2 External Control Set
EUDAMEDClass IVD General (EU MDR)
Ref PCRAE0135
Identity
- Trade Name
- VitaPCR SARS-CoV-2 Gen 2 External Control Set EUDAMED
- Device Name
- VitaPCR SARS-CoV-2 Gen2 External Control Set EUDAMED
- Model / Reference
- PCRAE0135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878570428 EUDAMED
- Basic UDI-DI
- B-04719878570428 EUDAMED
- EMDN Code
- W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VitaPCR SARS-CoV-2 Gen 2 External Control Set by Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04719878570428 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
- EUDAMED SRN
- TW-MF-000023414
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED db51ed3f-18b1-418e-9e2e-74c83df0c632 61 fields · synced Jul 12, 2026