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Dynamiker Fungus (1-3)-β-D-Glucan Assay(Chromogenic)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-1Model 12 tests(A)Model 24 testsModel 12 tests(B)Model 6 tests
Identity
- Device Name
- Dynamiker Fungus (1-3)-β-D-Glucan Assay(Chromogenic) EUDAMED
- Model / Reference
- 12 tests(A) EUDAMEDDNK-1901-1 EUDAMED24 tests EUDAMED12 tests(B) EUDAMED6 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317807334 EUDAMED06930317800816 EUDAMED06930317807327 EUDAMED06930317800830 EUDAMED
- Basic UDI-DI
- B-06930317807334 EUDAMEDB-06930317800816 EUDAMEDB-06930317807327 EUDAMEDB-06930317800830 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - 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
Yes
EUDAMED
Microbial Substances
Yes
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
Category: Nucleic acid extraction/isolation kit IVD
Dynamiker Fungus (1-3)-β-D-Glucan Assay(Chromogenic) by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06930317807334 | 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 (4)
- EUDAMED 7134293d-5e7d-4fb1-8f06-f714db2120a1 61 fields · synced Jul 27, 2026
- EUDAMED 69820175-0027-4c7f-ba96-b0906ddc2940 61 fields · synced May 17, 2026
- EUDAMED 38a41fd6-8824-4f11-b846-07e1de00de6f 61 fields · synced May 17, 2026
- EUDAMED 8618dd20-3da7-4e92-b051-0cc9735cf9d9 61 fields · synced May 18, 2026