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Biological Indicators For Sterilization
EUDAMEDClass I (EU MDR)
Ref BIO-STEAM 8X10X55MMModel BIO-STEAM; BIO-ETO; BIO-PLA
Identity
- Device Name
- BIOLOGICAL INDICATORS FOR STERILIZATION EUDAMED
- Model / Reference
- BIO-STEAM; BIO-ETO; BIO-PLA EUDAMEDBIO-STEAM 8X10X55MM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974409692934 EUDAMED
- Basic UDI-DI
- 697440969IndicatorsHV EUDAMED
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (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 Indicators For Sterilization by Mediwish 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 | 697440969IndicatorsHV | Class I | Active |
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Manufacturer
- Manufacturer
- Mediwish Co., Ltd
- EUDAMED SRN
- CN-MF-000008849
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9bfa5481-d4b5-4751-a9e8-2e537e46adc2 61 fields · synced Jun 19, 2026