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Sterilance
EUDAMEDClass I (EU MDR)
Ref 06-021218Model 75% Ethyl Alcohol, 70% Isopropyl Alcohol
Identity
- Trade Name
- Sterilance EUDAMED
- Device Name
- Alcohol Swabs EUDAMED
- Model / Reference
- 75% Ethyl Alcohol, 70% Isopropyl Alcohol EUDAMED06-021218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630142458 EUDAMED
- Basic UDI-DI
- 6945630106BK EUDAMED
- EMDN Code
- D0701 ETHANOL FOR THE DISINFECTION OF MEDICAL DEVICES 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
Sterilance by Sterilance Medical (Suzhou) Inc. — 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 | 6945630106BK | Class I | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED bbc1b3a0-8353-40d2-a038-a07858ad2199 61 fields · synced May 23, 2026