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Hot & Cold solution
EUDAMEDClass I (EU MDR)
Ref VISSCO ACTIVE FLEXI HOT & COLD GEL PACK
Identity
- Device Name
- Hot & Cold solution EUDAMED
- Model / Reference
- VISSCO ACTIVE FLEXI HOT & COLD GEL PACK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89043912040044 EUDAMED
- Basic UDI-DI
- 89043912465568J EUDAMED
- Direct Marketing DI
- 89043912040044 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Hot & Cold solution by Vissco Rehabilitation Aids Pvt Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
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- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- 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 | 89043912465568J | Class I | Active |
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Manufacturer
- Manufacturer
- Vissco Rehabilitation Aids Pvt Ltd.
- EUDAMED SRN
- IN-MF-000036725
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 23c0b2a2-c0aa-456d-a6d1-0766b3408b6c 61 fields · synced Jun 17, 2026