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Kylmägeeli ratiopharm 150 ml
EUDAMEDClass I (EU MDR)
Ref 321896Ref 350143/665001Model 350143
Identity
- Trade Name
- Kylmägeeli ratiopharm 150 ml EUDAMED
- Device Name
- Kylmägeeli ratiopharm EUDAMEDCOLD GEL EUDAMED
- Model / Reference
- 321896 EUDAMED350143 EUDAMED350143/665001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430020731440 EUDAMED06420615711001 EUDAMED
- Basic UDI-DI
- B-06430020731440 EUDAMED642061571350143B6 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Finland 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
Kylmägeeli ratiopharm 150 ml by Galena Pharma Oy — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06430020731440 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06430020731440 | Class I | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (2)
- EUDAMED de5ee66b-9546-47cb-8a25-53f142427d44 61 fields · synced Jul 22, 2026
- EUDAMED d91189fb-8292-4c7a-920f-6ca7a3136720 61 fields · synced May 18, 2026