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Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref 20 tests/ kitRef 5 tests/ kit
Identity
- Device Name
- Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold) EUDAMED
- Model / Reference
- 20 tests/ kit EUDAMED5 tests/ kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491761041 EUDAMED06975491761027 EUDAMED
- Basic UDI-DI
- B-06975491761041 EUDAMEDB-06975491761027 EUDAMED
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold) by Shenzhen Sciarray Biotech 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-06975491761041 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sciarray Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000038307
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED e2d0f890-9b61-4d3a-bd6f-96759fe4cf7e 61 fields · synced Aug 4, 2026
- EUDAMED 2f03fb05-59f0-4ddf-9fc8-a8def6ab8cf0 61 fields · synced May 18, 2026