Identity
- Trade Name
- Physiologix Hot & Cold 3-IN-1 Brace EUDAMED
- Device Name
- Hot and cold Pack EUDAMED
- Model / Reference
- MD481 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05099390410150 EUDAMED
- Basic UDI-DI
- 5099390HocopaRS EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Category: Hot/cold therapy pack, reusable
Physiologix Hot & Cold 3-IN-1 Brace by Fleming Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 | 5099390HocopaRS | Class I | Active |
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Manufacturer
- Manufacturer
- Fleming Medical
- EUDAMED SRN
- IE-MF-000044303
Sources (1)
- EUDAMED 47f1e68e-94b7-4ee7-9082-4e3b6dbaf9ea 61 fields · synced Jul 31, 2026