Identity
- Trade Name
- DENTAL XL EUDAMED
- Device Name
- FACE MASKS EUDAMEDSTERILIZATION REELS AND BAGS EUDAMEDCOTTON PELLETS EUDAMED
- Model / Reference
- DXL171 EUDAMEDDXL212 EUDAMEDDXL222 EUDAMEDDXL220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476626587 EUDAMED04250476625016 EUDAMED04250476607753 EUDAMED04250476607692 EUDAMED
- Basic UDI-DI
- 42504766FAMTD EUDAMED42504766STAB EUDAMED42504766COPAAG5 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMEDS01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMEDQ0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Dental Xl by Akzenta International SA — 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 | 42504766FAMTD | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (4)
- EUDAMED cb640d46-c5f1-47bb-9712-b72a4379b679 61 fields · synced Oct 6, 2026
- EUDAMED f132d217-0a42-4871-b24f-8632a5fa7dcf 61 fields · synced May 17, 2026
- EUDAMED a713145e-d2fa-4309-aed6-d2d2a5cc71c0 61 fields · synced Jul 20, 2026
- EUDAMED e3b2e60b-f82c-46ec-b3a8-5b68330df2cd 61 fields · synced Jul 20, 2026