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E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref MI-F43001Ref /
Identity
- Trade Name
- E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit EUDAMED
- Device Name
- E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit EUDAMEDCrypto/Giardia combo Test EUDAMED
- Model / Reference
- MI-F43001 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804827144 EUDAMEDD-MI-F42002N4 EUDAMED
- Basic UDI-DI
- B-06952804827144 EUDAMEDB-MI-F42002N4 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMEDW0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit by Assure Tech. (hangzhou) Co., Ltd. — 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-06952804827144 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED fe17d906-f4c7-440f-8e36-ff82c0d7ef8e 61 fields · synced Jul 24, 2026
- EUDAMED e776aeae-16ec-444a-9a81-79b948bbb19d 61 fields · synced Jul 24, 2026