← Back to catalogue
Antiseptic Applicator
EUDAMEDClass I (EU MDR)
Ref 44001Model Antiseptic Applicator
Identity
- Trade Name
- Antiseptic Applicator EUDAMED
- Device Name
- Antiseptic Applicator EUDAMED
- Model / Reference
- Antiseptic Applicator EUDAMED44001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095440018 EUDAMED
- Basic UDI-DI
- 890209544000ET EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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: Surgical utensil washer/disinfector
Antiseptic Applicator by Poly Medicure Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical utensil washer/disinfector.
- Steelco — STEELCO SPA · Class II
- WD1260-SC-060 — Smeg S.p.A. · Class IIb
- Getinge Aquadis Index — GETINGE DISINFECTION AB · Class IIa
- Sümer — SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIb
- Getinge ED-FLOW AER RANGE — GETINGE DISINFECTION AB · Class IIb
- CS 750 — Belimed Infection Control AG · Class IIa
- WD7015TM — Smeg S.p.A. · Class IIb
- AF2.60XMEG — AT-OS SRL · Class IIa
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 | 890209544000ET | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043011
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2f050188-a410-4ce2-bce5-626cce6ca81d 61 fields · synced Jun 19, 2026