Identity
- Trade Name
- THERMCOOL COMP COUDE EUDAMED
- Device Name
- Reusable Hot and Cold Pack EUDAMED
- Model / Reference
- THERMCOOL&HOT EUDAMED11521AP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03614790001580 EUDAMED
- Basic UDI-DI
- 64317creusableGS EUDAMED
- Direct Marketing DI
- 03614790001580 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Thermcool Comp Coude by Rapid Aid Vietnam Co., Ltd — 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 | 64317creusableGS | Class I | Active |
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Manufacturer
- Manufacturer
- Rapid Aid Vietnam Co., Ltd
- EUDAMED SRN
- VN-MF-000033576
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 7c7441ae-5b73-4970-8bf1-04961cb7c16a 61 fields · synced Jul 10, 2026