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Myocalm
EUDAMEDClass IIa (EU MDR)
Ref MYOPAT4Model Heat Patch Skin Adhesive SP 586Ref PDF004713Z
Identity
- Trade Name
- Myocalm EUDAMED
- Device Name
- Heat Patch Skin Adhesive SP 586 EUDAMED
- Model / Reference
- Heat Patch Skin Adhesive SP 586 EUDAMEDMYOPAT4 EUDAMEDPDF004713Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033549310752 EUDAMED08033549311124 EUDAMED
- Basic UDI-DI
- 803354931FTMDR01KJ EUDAMED
- Direct Marketing DI
- 08033549310752 EUDAMED08033549311124 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Myocalm by Zeta S.r.l. - MF — Class IIa — 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 | 803354931FTMDR01KJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zeta S.r.l. - MF
- EUDAMED SRN
- IT-MF-000017619
Sources (2)
- EUDAMED d84b0c01-c814-4c57-8b77-6ddc7867f67a 61 fields · synced Jul 10, 2026
- EUDAMED 40b5cac2-dc8d-4d26-898d-ade8c3419674 61 fields · synced May 17, 2026