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Monkeypox virus (MPXV) Antigen Rapid Test Cassette
EUDAMEDClass IVD General (EU MDR)
Ref G10P50-X1Ref G10P-SRef G10P50-X1-DRef G10P5-X1Ref G10P20-X1Ref G10P20-X1-D
Identity
- Device Name
- Monkeypox virus (MPXV) Antigen Rapid Test Cassette EUDAMED
- Model / Reference
- G10P50-X1 EUDAMEDG10P-S EUDAMEDG10P50-X1-D EUDAMEDG10P5-X1 EUDAMEDG10P20-X1 EUDAMEDG10P20-X1-D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323017035 EUDAMED06974323011972 EUDAMED06974323011927 EUDAMED06974323017073 EUDAMED06974323017011 EUDAMED06974323017028 EUDAMED06974323011903 EUDAMED06974323017066 EUDAMED06974323011934 EUDAMED06974323011910 EUDAMED
- Basic UDI-DI
- B-06974323017035 EUDAMEDB-06974323011972 EUDAMEDB-06974323011927 EUDAMEDB-06974323017073 EUDAMEDB-06974323017011 EUDAMEDB-06974323017028 EUDAMEDB-06974323011903 EUDAMEDB-06974323017066 EUDAMEDB-06974323011934 EUDAMEDB-06974323011910 EUDAMED
- EMDN Code
- W0105099008 MONKEYPOX VIRUS / MPOX RT & POC 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
Monkeypox virus (MPXV) Antigen Rapid Test Cassette by Beijing Applied Biological Technologies 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-06974323017035 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (10)
- EUDAMED 914df403-f427-47f4-8f03-16acd47162cc 61 fields · synced Sep 18, 2026
- EUDAMED 4b91c9f1-6f79-4de1-ad30-eca030f1a41d 61 fields · synced May 17, 2026
- EUDAMED 2a908fc5-838e-4968-91ca-024a99766ad2 61 fields · synced May 17, 2026
- EUDAMED f6d31727-5773-4a03-9186-847799beb60f 61 fields · synced May 17, 2026
- EUDAMED b12f479b-79d1-4064-ac83-cae41e407481 61 fields · synced May 18, 2026
- EUDAMED 264d1ae2-4e2f-43a3-be3d-0a0a8ac8b9a5 61 fields · synced May 18, 2026
- EUDAMED 52a6c2cf-4a86-4d8c-af69-e13acd22cac4 61 fields · synced May 18, 2026
- EUDAMED 821983be-7395-4102-806e-12b33a5618e9 61 fields · synced May 19, 2026
- EUDAMED 76d09a28-a995-44b1-b394-54d150750950 61 fields · synced May 19, 2026
- EUDAMED daf52676-d072-43d0-97f8-6352d754f005 61 fields · synced May 19, 2026