Identity
- Trade Name
- Silverman Head Support EUDAMEDBlessing Cathay FDA UDI
- Generic Name
- Head/neck procedure positioner FDA UDI
- Device Name
- Radiological Positioning Holders, Cradles and Accessories EUDAMED
- Model / Reference
- SILVER-D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879741216 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987974RT58 EUDAMED
- FDA Product Code
- IWY FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Head/neck procedure positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1920 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silverman Head Support by Blessing Cathay Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987974RT58 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 382df37f-ef0a-4ff1-9b72-b5b431fc6d2e 61 fields · synced Jun 19, 2026
- FDA UDI a8757163-a223-4ebf-a462-998358a3d1d3 32 fields · synced May 30, 2026