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Saliva DNA Sample Collection Kit
EUDAMEDClass A (EU MDR)
Ref 401103Model SAL-2000L
Identity
- Trade Name
- Saliva DNA Sample Collection Kit EUDAMED
- Device Name
- Saliva DNA Sample Collection Kit EUDAMEDIVD Sample Collection Kit EUDAMED
- Model / Reference
- SAL-2000L EUDAMED401103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299702214 EUDAMED
- Basic UDI-DI
- 695629970005P7 EUDAMED
- Direct Marketing DI
- 06956299702214 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Saliva DNA Sample Collection Kit by Xiamen Zeesan Biotech Co., Ltd. — Class A — 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 | 695629970005P7 | Class A | 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 (2)
- EUDAMED aeb5de68-a498-4855-92aa-edcdaad12f64 61 fields · synced Oct 6, 2026
- EUDAMED f619d431-c8d0-41c5-871e-924211e670b7 61 fields · synced Jul 30, 2026