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Biological Indicator
EUDAMEDClass I (EU MDR)
Ref BI102Model BI101 BI102 BI103 BI104Ref BI104
Identity
- Device Name
- Biological Indicator EUDAMED
- Model / Reference
- BI101 BI102 BI103 BI104 EUDAMEDBI102 EUDAMEDBI104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978563510271 EUDAMED06978563510295 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
Biological Indicator by Nantong Ineuthink Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (2)
- EUDAMED 0d52701d-7c1f-413b-a559-1d7ef96f6e11 61 fields · synced Aug 1, 2026
- EUDAMED 8d0f08ca-a37f-43e3-8274-7fefc8d4a2f0 61 fields · synced May 18, 2026