Identity
- Trade Name
- WELLS EUDAMEDWells - Fita cinesioterapia EUDAMED
- Device Name
- INSTANT ICE PACK EUDAMEDBENDA ELASTICA ADESIVA KINETIC EUDAMED
- Model / Reference
- GIS000818 EUDAMEDBK003277 EUDAMEDBK003284 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600954000818 EUDAMED05600954003277 EUDAMED05600954003284 EUDAMED
- Basic UDI-DI
- B-05600954000818 EUDAMED8017990BKU6 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMEDZ12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Portugal 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
Wells by Eurosirel Spa — Class IIa — 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-05600954000818 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05600954000818 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (3)
- EUDAMED a3c2d1ee-27d8-4994-9b7a-6a57c3e50fbc 61 fields · synced Jul 23, 2026
- EUDAMED 94d94b9a-165c-4139-9435-9472bb0f172f 61 fields · synced May 17, 2026
- EUDAMED dd244b4a-c3cd-469e-87d2-a2b694fc849a 61 fields · synced May 18, 2026