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Fungus (1-3)-β-D Glucan Control
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-2Model Type A4: R2 and R4 (4 pcs. respectively)Model Type B2: R1, R2 and R4 (2 pcs. respectively)Model Type B4: R1, R2 and R4 (4 pcs. respectively)Model Type C2: R1, R2, R3 and R4 (2 pcs. respectively)Model Type A1: R2 and R4 (1 pc. respectively)Model Type C4: R1, R2, R3 and R4 (4 pcs. respectively)Model Type C1: R1, R2, R3 and R4 (1 pc. respectively)
Identity
- Device Name
- Fungus (1-3)-β-D Glucan Control EUDAMED
- Model / Reference
- Type A4: R2 and R4 (4 pcs. respectively) EUDAMEDDNK-1901-2 EUDAMEDType B2: R1, R2 and R4 (2 pcs. respectively) EUDAMEDType B4: R1, R2 and R4 (4 pcs. respectively) EUDAMEDType C2: R1, R2, R3 and R4 (2 pcs. respectively) EUDAMEDType A1: R2 and R4 (1 pc. respectively) EUDAMEDType C4: R1, R2, R3 and R4 (4 pcs. respectively) EUDAMEDType C1: R1, R2, R3 and R4 (1 pc. respectively) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317800748 EUDAMED06930317800724 EUDAMED06930317801028 EUDAMED06930317801042 EUDAMED06930317800809 EUDAMED06930317801059 EUDAMED06930317801035 EUDAMED
- Basic UDI-DI
- B-06930317800748 EUDAMEDB-06930317800724 EUDAMEDB-06930317801028 EUDAMEDB-06930317801042 EUDAMEDB-06930317800809 EUDAMEDB-06930317801059 EUDAMEDB-06930317801035 EUDAMED
- EMDN Code
- W0101050299 SPECIFIC CONTROLS (CC) - 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
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Fungus (1-3)-β-D Glucan Control by Dynamiker Biotechnology (Tianjin) 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-06930317800748 | 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 (7)
- EUDAMED 4687bea2-5108-45af-99c8-0d33f2ce7276 61 fields · synced Aug 4, 2026
- EUDAMED 23bdbbfe-f25e-4d69-827d-7ea9edfe51b8 61 fields · synced May 16, 2026
- EUDAMED ca5e3f79-a994-4f35-b5be-3bf376850077 61 fields · synced May 17, 2026
- EUDAMED 3046d2fe-06f3-45a6-afa6-b158a1722051 61 fields · synced May 17, 2026
- EUDAMED 985a7850-797b-4337-9738-021810ac0bf8 61 fields · synced May 17, 2026
- EUDAMED af231c71-10ed-406b-95ba-533053431351 61 fields · synced May 17, 2026
- EUDAMED f376ffcd-4c1c-4a09-80d0-2eb9a29a8aec 61 fields · synced May 18, 2026