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Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1411-1Model 50 tests(A)Model 40 tests(A)
Identity
- Device Name
- Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA) EUDAMED
- Model / Reference
- 50 tests(A) EUDAMEDDNK-1411-1 EUDAMED40 tests(A) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317834774 EUDAMED06930317804319 EUDAMED
- Basic UDI-DI
- B-06930317834774 EUDAMEDB-06930317804319 EUDAMED
- EMDN Code
- W0105060303 CRYPTOCOCCUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA) by Dynamiker Biotechnology (Tianjin) 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-06930317834774 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 2d54d508-ca33-40dd-ba49-23588f74eb87 61 fields · synced Jul 27, 2026
- EUDAMED 138b9b7e-5aac-4d74-bbe7-70d400e994ae 61 fields · synced May 17, 2026