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Kalt-Warm-Kompresse
EUDAMEDClass I (EU MDR)
Ref L09161701Ref L13141701Ref L16261101Ref L21381701Ref L16261701Ref L12291701Ref L12291101Ref L75521101Ref L75351701
Identity
- Trade Name
- Kalt-Warm-Kompresse EUDAMED
- Device Name
- Kalt-Warm-Kompresse EUDAMED
- Model / Reference
- L09161701 EUDAMEDL13141701 EUDAMEDL16261101 EUDAMEDL21381701 EUDAMEDL16261701 EUDAMEDL12291701 EUDAMEDL12291101 EUDAMEDL75521101 EUDAMEDL75351701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251765100078 EUDAMED04251765100115 EUDAMED04251765100139 EUDAMED04251765100191 EUDAMED04251765100153 EUDAMED04251765100030 EUDAMED04251765100016 EUDAMED04251765100252 EUDAMED04251765100238 EUDAMED
- Basic UDI-DI
- 42517651AG10AG15X2 EUDAMED
- Direct Marketing DI
- 04251765100078 EUDAMED04251765100115 EUDAMED04251765100139 EUDAMED04251765100191 EUDAMED04251765100153 EUDAMED04251765100030 EUDAMED04251765100016 EUDAMED04251765100252 EUDAMED04251765100238 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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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 | 42517651AG10AG15X2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gello GmbH Geltechnik
- EUDAMED SRN
- DE-MF-000010607
Sources (9)
- EUDAMED ac38a296-3b3d-4126-9657-ec9e59c10a27 61 fields · synced Sep 17, 2026
- EUDAMED 1e5e2d1e-70f3-4eb8-ad1d-3b5ac6c30417 61 fields · synced May 17, 2026
- EUDAMED 6ba4ae1b-2b52-43b9-80bf-48a4e777e168 61 fields · synced May 18, 2026
- EUDAMED db3a0e16-bec2-41af-8857-a3a08f153bf5 61 fields · synced May 18, 2026
- EUDAMED 1393c593-d167-4a13-952e-90ca1ee08863 61 fields · synced May 18, 2026
- EUDAMED 3b30081f-cdf8-4aab-843b-64aaf645e869 61 fields · synced May 18, 2026
- EUDAMED db9115e7-3549-4289-9933-d416afab67b3 61 fields · synced May 18, 2026
- EUDAMED 80bf6c67-3a6d-483f-b14f-e9553d712b57 61 fields · synced May 18, 2026
- EUDAMED 465946d7-9728-42ff-882f-b0834eb34cb2 61 fields · synced May 18, 2026