Identity
- Trade Name
- ZEESAN EUDAMEDMTB/MDR Test Kit (Sanity 2.0) EUDAMED
- Device Name
- MTB/MDR Test Kit (Sanity 2.0) EUDAMED
- Model / Reference
- 801181 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299702870 EUDAMED
- Basic UDI-DI
- B-06956299702870 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMEDW0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMEDItaly 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
Zeesan 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-06956299702870 | 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 (2)
- EUDAMED 25f5158c-921c-4ed7-a0a6-e7c1ced41919 61 fields · synced Jun 18, 2026
- EUDAMED 5f54b250-9080-4bee-bf2b-c6cdb4c76038 61 fields · synced Jun 18, 2026