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Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)
EUDAMEDClass IVD General (EU MDR)
Ref MPX00120Ref MPX00405Ref MPX00505Ref MPX00205Model MPX00220Ref MPX00501Ref MPX00420Ref MPX00101Model MPX00105Model MPX00301
Identity
- Trade Name
- Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) EUDAMED
- Device Name
- Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) EUDAMED
- Model / Reference
- MPX00120 EUDAMEDMPX00405 EUDAMEDMPX00505 EUDAMEDMPX00220 EUDAMEDMPX00205 EUDAMEDMPX00501 EUDAMEDMPX00420 EUDAMEDMPX00105 EUDAMEDMPX00101 EUDAMEDMPX00301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975146600152 EUDAMED06975146600237 EUDAMED06975146600268 EUDAMED06975146600183 EUDAMED06975146600251 EUDAMED06975146600244 EUDAMED06975146600145 EUDAMED06975146600176 EUDAMED06975146600190 EUDAMED
- Basic UDI-DI
- B-06975146600152 EUDAMEDB-06975146600237 EUDAMEDB-06975146600268 EUDAMEDB-06975146600183 EUDAMEDB-06975146600251 EUDAMEDB-06975146600244 EUDAMEDB-06975146600145 EUDAMEDB-06975146600176 EUDAMEDB-06975146600190 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER 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
Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) by BioDetect（Xiamen）Biotechnology 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-06975146600152 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- BioDetect（Xiamen）Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001098
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (9)
- EUDAMED 8a606a46-f50f-43ed-b0cc-65f549b2d6c2 61 fields · synced Aug 4, 2026
- EUDAMED 49d52e41-b04d-485f-8973-8304c2f87e5c 61 fields · synced May 16, 2026
- EUDAMED 13722c21-f6cb-4d55-9929-3c8ba61bbf4a 61 fields · synced May 17, 2026
- EUDAMED 7fd2aeea-62dd-413f-888d-66ecd3a84927 61 fields · synced May 17, 2026
- EUDAMED 56fc5db7-aa86-49d5-b135-ddc3e9623243 61 fields · synced May 18, 2026
- EUDAMED 75e2f0eb-3cfe-44a1-b244-4875e6da91f4 61 fields · synced May 18, 2026
- EUDAMED 92310c15-03ac-4bee-a655-57533da9862c 61 fields · synced May 19, 2026
- EUDAMED e9fd3968-f0c0-4946-a1d2-819c3a9db331 61 fields · synced May 19, 2026
- EUDAMED 3da07bf2-f97d-4331-bb91-d71a01ce7830 61 fields · synced May 19, 2026