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Automatic Biological Reader
EUDAMEDClass I (EU MDR)
Ref BI-8Model BI-3 BI-8 BI-10 BI-12Ref BI-12Ref BI-10
Identity
- Device Name
- Automatic Biological Reader EUDAMED
- Model / Reference
- BI-3 BI-8 BI-10 BI-12 EUDAMEDBI-8 EUDAMEDBI-12 EUDAMEDBI-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978563510363 EUDAMED06978563510387 EUDAMED06978563510370 EUDAMED
- Basic UDI-DI
- 697856351ABR01L8 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Automatic Biological Reader by Nantong Ineuthink Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697856351ABR01L8 | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong Ineuthink Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047513
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 431ee85f-0cfb-48a0-bf37-6cdfbfc9a268 61 fields · synced Oct 6, 2026
- EUDAMED 9e9c6360-5276-4f57-80b3-d0e5b5fabc1c 61 fields · synced May 17, 2026
- EUDAMED e6227abd-e575-4217-b965-e98fefbe5cbf 61 fields · synced May 18, 2026