Identity
- Trade Name
- Genetic Sequencer EUDAMED
- Device Name
- Genetic Sequencer EUDAMED
- Model / Reference
- UniSeq2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977211570018 EUDAMED
- Basic UDI-DI
- 697721157UniSeq2000KG EUDAMED
- Direct Marketing DI
- 06977211570018 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Genetic Sequencer by Jiangsu ME Instruments 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 | 697721157UniSeq2000KG | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu ME Instruments Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000041672
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 19e5bfe1-de92-490a-aa44-b4d24a5fbf2b 61 fields · synced Jul 10, 2026