Identity
- Device Name
- Mask for Radiation therapy EUDAMED
- Model / Reference
- Many EUDAMEDRG461-5VHT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920824113745 EUDAMED
- Basic UDI-DI
- 692082411035CE EUDAMED
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Mask for Radiation therapy by Klarity Medical & Equipment（GZ） Co., Ltd. — 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 | 692082411035CE | Class I | Active |
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Manufacturer
- Manufacturer
- Klarity Medical & Equipment（GZ） Co., Ltd.
- EUDAMED SRN
- CN-MF-000002229
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 18940b8d-3310-4a40-a88a-d87ac721dee0 61 fields · synced Jun 18, 2026