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Sanity-2 Respiratory Pathogen Panel (RPP3)
EUDAMEDClass IVD General (EU MDR)
Ref 801114
Identity
- Trade Name
- Sanity-2 Respiratory Pathogen Panel (RPP3) EUDAMED
- Device Name
- Sanity-2 Respiratory Pathogen Panel (RPP3) EUDAMED
- Model / Reference
- 801114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299703297 EUDAMED
- Basic UDI-DI
- B-06956299703297 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sanity-2 Respiratory Pathogen Panel (RPP3) by Xiamen Zeesan Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06956299703297 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Zeesan Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 27a458f5-00f1-4ac4-99f5-b63c6d929da5 61 fields · synced Aug 3, 2026