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Biological Indicator
EUDAMEDClass I (EU MDR)
Ref BI103Model BI101 BI102 BI103 BI104
Identity
- Device Name
- Biological Indicator EUDAMED
- Model / Reference
- BI101 BI102 BI103 BI104 EUDAMEDBI103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978563510288 EUDAMED
- Basic UDI-DI
- 697856351BI01MV EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - 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: Sterilizer/disinfector rack
Biological Indicator 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 | 697856351BI01MV | 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 (1)
- EUDAMED 11d35a2a-5ed3-43e2-9af6-1f8cfaf5630d 61 fields · synced Jun 18, 2026