Identity
- Trade Name
- Relief Pak EUDAMED
- Device Name
- HOT AND COLD PRODUCTS EUDAMED
- Model / Reference
- 111000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00714905017147 EUDAMED
- Basic UDI-DI
- 714905TF06HCZT EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Relief Pak is a high-quality device designed for hot and cold products, offering effective relief from various pains and discomforts. This medical device has been rigorously tested to ensure its safety and efficacy in various settings.
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 | 714905TF06HCZT | Class I | Active |
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Manufacturer
- Manufacturer
- Fabrication Enterprises
- EUDAMED SRN
- US-MF-000014521
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (1)
- EUDAMED debe53d6-f635-41cf-b235-56fe6394b8b6 61 fields · synced Jul 14, 2026