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Equalbit 1 x dsDNA HS Assay Kit
EUDAMEDClass A (EU MDR)
Ref EQ121ME-02Model EQ121ME
Identity
- Trade Name
- Equalbit 1 x dsDNA HS Assay Kit EUDAMEDEqualbit 1 × dsDNA HS Assay Kit EUDAMED
- Device Name
- Equalbit 1 × dsDNA HS Assay Kit EUDAMED
- Model / Reference
- EQ121ME EUDAMEDEQ121ME-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315736008 EUDAMED
- Basic UDI-DI
- 69733157360089S EUDAMED
- Direct Marketing DI
- 06973315736008 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Equalbit 1 x dsDNA HS Assay Kit by Nanjing Vazyme Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69733157360089S | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f08828d9-59c3-43c5-bd78-f80e21776ae8 61 fields · synced Jun 19, 2026
- EUDAMED 02f23bb3-b588-4718-82c4-375514c5dd4e 61 fields · synced Jun 19, 2026