Identity
- Trade Name
- AquaCast Thermoplastic EUDAMED
- Device Name
- Patient Immobilization Splinting Materials EUDAMED
- Model / Reference
- AC203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879741445 EUDAMED
- Basic UDI-DI
- 471987974RH4G EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES 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
AquaCast Thermoplastic 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 | 471987974RH4G | 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 (1)
- EUDAMED 4206c6a3-8b60-491e-829d-558403321f71 61 fields · synced Jul 23, 2026