Identity
- Device Name
- E.N.T Treatment Unit EUDAMED
- Model / Reference
- XU1 SMART EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800038900455 EUDAMED
- Basic UDI-DI
- B-08800038900455 EUDAMED
- EMDN Code
- Z121402 ENT TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: ENT examination/treatment system
E.N.T Treatment Unit by Dong-A Chammed Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as ENT examination/treatment system.
- Wall diagnostic ri-former® 2 handles 3.5 V / 120 V without clock — Rudolf Riester GmbH & Co. KG · Class II
- ATMOS S 61 Servant instruments XL — ATMOS MedizinTechnik GmbH & Co. KG · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- ATMOS C 21 Economy - function column (127 V~) — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- Optomic — OPTOMIC ESPAÑA SA · Class I
- ATMOS S 61 Servant instruments — ATMOS MedizinTechnik GmbH & Co. KG · Class I
- ATMOS S 61 Servant ENT workstation (230 V~) — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- Extension module, 1 handle, ri-former® — Rudolf Riester GmbH & Co. KG · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800038900455 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dong-A Chammed Co., Ltd.
- EUDAMED SRN
- KR-MF-000021773
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 7215cddb-e80c-4d2d-9817-c6e248cdf8a7 61 fields · synced Jul 28, 2026