Identity
- Trade Name
- Kalt-Warm-Kompresse EUDAMED
- Device Name
- Kalt-Warm-Kompresse EUDAMED
- Model / Reference
- L09161101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251765100054 EUDAMED
- Basic UDI-DI
- 42517651AG10AG15X2 EUDAMED
- Direct Marketing DI
- 04251765100054 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
Kalt-Warm-Kompresse by Gello GmbH Geltechnik — 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 | 42517651AG10AG15X2 | Class I | Active |
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Manufacturer
- Manufacturer
- Gello GmbH Geltechnik
- EUDAMED SRN
- DE-MF-000010607
Sources (1)
- EUDAMED 93bcc64d-92ba-421f-99da-c5d4fd5cf5cc 61 fields · synced Jun 17, 2026