← Back to catalogue
Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT078AModel 50 tests/kit
Identity
- Trade Name
- Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) EUDAMED
- Device Name
- Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-RT078A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366167 EUDAMED
- Basic UDI-DI
- B-06974849366167 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD…
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-06974849366167 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 62fb9fbd-1e47-452e-a44f-086f4662e83d 61 fields · synced Jun 19, 2026