Identity
- Trade Name
- Gamma Knife Mask EUDAMED
- Device Name
- Radiological Positioning Holders, Cradles and Accessories EUDAMED
- Model / Reference
- PPT-621 EUDAMEDPPT-681 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879740448 EUDAMED04719879740875 EUDAMED
- Basic UDI-DI
- 471987974RT58 EUDAMED
- EMDN Code
- T030401 RADIOTHERAPY PROTECTION MASKS 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
Gamma Knife Mask by Blessing Cathay Corporation — 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 | 471987974RT58 | Class I | Active |
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Manufacturer
- Manufacturer
- Blessing Cathay Corporation
- EUDAMED SRN
- TW-MF-000033419
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 41674745-5c64-4bd0-8242-0f97e1c31f5b 61 fields · synced Jul 29, 2026
- EUDAMED 6f4c01c8-7608-4f94-aa20-a4d77db52b63 61 fields · synced May 18, 2026