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ONEblot Near-Field Chemi lmager
EUDAMEDClass A (EU MDR)
Ref H511001Model ONEblot Dx
Identity
- Device Name
- ONEblot Near-Field Chemi lmager EUDAMED
- Model / Reference
- ONEblot Dx EUDAMEDH511001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974149860044 EUDAMED
- Basic UDI-DI
- 697414986ONEblotDxC6 EUDAMED
- Direct Marketing DI
- 06974149860044 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
ONEblot Near-Field Chemi lmager by Aperbio Technologies (Suzhou) 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 | 697414986ONEblotDxC6 | Class A | Active |
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Manufacturer
- Manufacturer
- Aperbio Technologies (Suzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000045149
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED acd164f6-451c-4d59-b180-6d288d216364 61 fields · synced Jun 17, 2026