Identity
- Trade Name
- DermaPlast ACTIVE Cool Gel EUDAMED
- Device Name
- Sportgel EUDAMED
- Model / Reference
- 69447 EUDAMED69444 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 4052199288673 EUDAMED4052199283227 EUDAMED
- Basic UDI-DI
- PP27855KUEHLGEL252 EUDAMED
- Direct Marketing DI
- 4052199288673 EUDAMED4052199283227 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES 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
Category: Hot/cold therapy pack, reusable
DermaPlast ACTIVE Cool Gel by Sportomed GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | PP27855KUEHLGEL252 | Class I | Active |
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Manufacturer
- Manufacturer
- Sportomed GmbH
- EUDAMED SRN
- DE-MF-000006642
Sources (2)
- EUDAMED cfe49d8d-dd21-469f-90c9-a45a8ce73cef 61 fields · synced Jul 30, 2026
- EUDAMED 2190748a-9aed-4712-9378-b5bb3c1ead68 61 fields · synced May 16, 2026