← Back to catalogue
Haemophilus influenzae (HI) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probi…
EUDAMEDClass IVD General (EU MDR)
Ref S3280E-48
Identity
- Device Name
- Haemophilus influenzae (HI) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3280E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792735675 EUDAMED
- Basic UDI-DI
- B-06955792735675 EUDAMED
- EMDN Code
- W0105011610 HAEMOPHILUS INFLUENZAE - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
Haemophilus influenzae (HI) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probi… by Sansure Biotech Inc. — 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-06955792735675 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 492bb433-2d45-4133-9286-ad2623583a1f 61 fields · synced Jun 18, 2026