Identity
- Trade Name
- Intrinsic Plus Resting Splint EUDAMED
- Device Name
- Patient Immobilization Splinting Materials EUDAMED
- Model / Reference
- IS-295 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879741131 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
Intrinsic Plus Resting Splint 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 8729a259-b6fa-40f6-99a3-1f165397bf3a 61 fields · synced Jul 24, 2026