← Back to catalogue
Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time …
EUDAMEDClass IVD General (EU MDR)
Ref FPCR-50Ref FAPCR-25
Identity
- Trade Name
- Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time PCR) EUDAMED
- Device Name
- Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time PCR) EUDAMEDAspergillus Molecular Detection Kit (Real-time PCR) EUDAMED
- Model / Reference
- FPCR-50 EUDAMEDFAPCR-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514080994 EUDAMED06970514081007 EUDAMED
- Basic UDI-DI
- B-06970514080994 EUDAMEDB-06970514081007 EUDAMED
- EMDN Code
- W0105060499 MYCOLOGY NA REAGENTS - OTHER EUDAMEDW0105060401 ASPERGILLUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time … by Genobio Pharmaceutical Co., Ltd. — Class IVD General — IVDD — listed in…
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-06970514080994 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000027997
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 4f419fbf-f523-4996-863e-4bdc1be39320 61 fields · synced Jul 18, 2026
- EUDAMED fd925da0-dc5a-4572-9491-e0c6ca0d943e 61 fields · synced Jul 18, 2026