Identity
- Trade Name
- Astroplast EUDAMED
- Device Name
- Sterile Saline Wound Cleansing Wipe EUDAMED
- Model / Reference
- 1601026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15017599001617 EUDAMED
- Basic UDI-DI
- 5017599000TF11WN EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern 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
Astroplast by Naturelle Consumer Products — Class IIa — 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 | 5017599000TF11WN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Naturelle Consumer Products
- EUDAMED SRN
- XI-MF-000018016
Sources (1)
- EUDAMED 2e0b1498-0cd9-425c-8e72-f7da8007925e 61 fields · synced Oct 6, 2026