Identity
- Device Name
- Sanger Sequencing EUDAMED
- Model / Reference
- T400 EUDAMEDA02010011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500545 EUDAMED
- Basic UDI-DI
- 069370445sseqA02010001JE EUDAMED
- Direct Marketing DI
- 06937044500545 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Sanger Sequencing by Ningbo HEALTH Gene Technologies 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 | 069370445sseqA02010001JE | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED da7bae14-0b8a-4884-9e83-84588769135b 61 fields · synced Jul 31, 2026