Identity
- Trade Name
- Hypaclean EUDAMED
- Device Name
- Sterile Saline Wound Cleansing Wipe EUDAMED
- Model / Reference
- D5201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15017599002119 EUDAMED
- Basic UDI-DI
- 5017599000TF11WN EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Category: Device sterilization/disinfection container, reusable
Hypaclean by Naturelle Consumer Products — Class IIa — 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 | 5017599000TF11WN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Naturelle Consumer Products
- EUDAMED SRN
- XI-MF-000018016
Sources (1)
- EUDAMED acb3f71d-02fd-44c6-9abb-56beaa8e893d 61 fields · synced Oct 6, 2026