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Hot/cold reusable compress
EUDAMEDClass I (EU MDR)
Ref 4568944Model 100g~1000g ,5~50cm*10~50cm,etc.Ref 4569799
Identity
- Trade Name
- Hot/cold reusable compress EUDAMED
- Device Name
- Cold /Hot pack EUDAMED
- Model / Reference
- 100g~1000g ,5~50cm*10~50cm,etc. EUDAMED4568944 EUDAMED4569799 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03608390945351 EUDAMED03608390946419 EUDAMED
- Basic UDI-DI
- 69228209MDN1214IN0000145Q EUDAMED
- Direct Marketing DI
- 03608390945351 EUDAMED03608390946419 EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Hot/cold reusable compress by RFX+CARE Manufacturing 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 | 69228209MDN1214IN0000145Q | 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 (2)
- EUDAMED 58923292-5cf7-4bd0-8d30-c33ff189b963 61 fields · synced Jul 24, 2026
- EUDAMED 5b43f2a4-0564-43a5-b382-ea9dea377dfb 61 fields · synced May 19, 2026