← Back to catalogue
ARMS-PCR Detection Kit for SARS-CoV-2 L452R and E484Q Mutation
EUDAMEDClass IVD General (EU MDR)
Ref A9234YH-50T
Identity
- Device Name
- ARMS-PCR Detection Kit for SARS-CoV-2 L452R and E484Q Mutation EUDAMED
- Model / Reference
- A9234YH-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012023 EUDAMED
- Basic UDI-DI
- B-06974323012023 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS 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
ARMS-PCR Detection Kit for SARS-CoV-2 L452R and E484Q Mutation by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974323012023 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 3b5dd168-832c-4c49-9f8d-a774b3204636 61 fields · synced Oct 6, 2026