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Sialic Acid (SA) Test Kit (Neuraminidase enzymic)
EUDAMEDClass IVD General (EU MDR)
Ref Calibrator：1mL×1(91056)Ref Quality Control：1mL×1(92047)Ref R1:60mL×2 R2:20mL×2(701)Ref R1:18mL×1 R2:6mL×1(702)Ref R1:18mL×4 R2:6mL×4(709)
Identity
- Trade Name
- Sialic Acid (SA) Test Kit (Neuraminidase enzymic) EUDAMED
- Device Name
- Sialic Acid (SA) Test Kit (Neuraminidase enzymic) EUDAMED
- Model / Reference
- Calibrator：1mL×1(91056) EUDAMEDQuality Control：1mL×1(92047) EUDAMEDR1:60mL×2 R2:20mL×2(701) EUDAMEDR1:18mL×1 R2:6mL×1(702) EUDAMEDR1:18mL×4 R2:6mL×4(709) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674868132 EUDAMED06971674868507 EUDAMED06971674869702 EUDAMED06971674869726 EUDAMED06971674869719 EUDAMED
- Basic UDI-DI
- B-06971674868132 EUDAMEDB-06971674868507 EUDAMEDB-06971674869702 EUDAMEDB-06971674869726 EUDAMEDB-06971674869719 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Sialic Acid (SA) Test Kit (Neuraminidase enzymic) by Biobase Biodustry(Shandong) 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-06971674868132 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (5)
- EUDAMED bf6fc192-41ec-42f9-9815-18962b878b36 61 fields · synced Oct 6, 2026
- EUDAMED 200ee4ea-9d91-4a11-9295-5345d09c3a7d 61 fields · synced May 16, 2026
- EUDAMED 612774d8-dbb0-40d6-bbb7-ef86340aa3d8 61 fields · synced May 16, 2026
- EUDAMED 930970aa-a5d8-4d40-b4fe-6b0ecf3f83a5 61 fields · synced May 18, 2026
- EUDAMED bfb865a7-18ab-4171-a1a3-7091b0c28e0f 61 fields · synced May 18, 2026