Identity
- Trade Name
- PoloDent Ultrasonic Cleaner Concentrate EUDAMED
- Device Name
- Ultrasonic Cleaner EUDAMED
- Model / Reference
- 830007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060493851256 EUDAMED
- Basic UDI-DI
- 1506049385UltrasonicJ6 EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Category: Medical device disinfection agent
PoloDent Ultrasonic Cleaner Concentrate by Topdental (Products) Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection agent.
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class I
- Instru Zym — Laboratorium Dr. Deppe GmbH · Class I
- Your First Enzymatic & Non-Enzymatic Sponges — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Rapidzyme PR — Novapharm Research (Australia) Pty Ltd · Class IIb
- Olie Medical Performance Enzymatic 5 — Amity Limited · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · Class I
- Sterilbios — AMIL CARE CORPORATION · Class I
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 | 1506049385UltrasonicJ6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Topdental (Products) Ltd
- EUDAMED SRN
- GB-MF-000003937
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (1)
- EUDAMED 720e4dc5-9934-4413-8188-1f9436c93c82 61 fields · synced Jul 22, 2026