← Back to catalogue
Equalbit 1 × dsDNA HS Assay Kit
EUDAMEDClass A (EU MDR)
Ref EQ121ME-01Model EQ121ME
Identity
- Trade Name
- Equalbit 1 × dsDNA HS Assay Kit EUDAMED
- Device Name
- Equalbit 1 × dsDNA HS Assay Kit EUDAMED
- Model / Reference
- EQ121ME EUDAMEDEQ121ME-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315736336 EUDAMED
- Basic UDI-DI
- 69733157360089S EUDAMED
- Direct Marketing DI
- 06973315736336 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 × 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 |
Is this your device? Claim it to add documentation and request validation.
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 (1)
- EUDAMED ca92be3c-608e-46dc-99c8-c33c81a50c1a 61 fields · synced Oct 6, 2026