Identity
- Trade Name
- Businesscare Saline Cleansing Wipe EUDAMED
- Device Name
- Wound Cleansing Wipes EUDAMED
- Model / Reference
- 94635-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032483000449 EUDAMED
- Basic UDI-DI
- 506013188CE04XK EUDAMED
- EMDN Code
- M04040101 SALINE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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
Businesscare Saline Cleansing Wipe by Reliance Medical (Shanghai) Limited — 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 | 506013188CE04XK | Class I | Active |
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Manufacturer
- Manufacturer
- Reliance Medical (Shanghai) Limited
- EUDAMED SRN
- CN-MF-000007382
- Authorised Representative
- Reliance Medical (Ireland) IE-AR-000003675
Sources (1)
- EUDAMED 0799dfe5-e49d-45e4-860a-f7d3c5b3077d 61 fields · synced Jun 18, 2026