Identity
- Trade Name
- HELTIQ Isolation blanket EUDAMED
- Device Name
- Emergency Blanket EUDAMED
- Model / Reference
- 210*160 cm EUDAMED556102R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717484792414 EUDAMED
- Basic UDI-DI
- B-08717484792414 EUDAMED
- EMDN Code
- T030399 HEATING COVERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HELTIQ Isolation blanket by RFX+CARE Manufacturing Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08717484792414 | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED ca924d0e-918b-41aa-b513-539cf2c6eb00 61 fields · synced Jul 25, 2026