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Cold/warm compress
EUDAMEDClass I (EU MDR)
Ref KCZ7513
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- Cold/warm compress EUDAMED
- Device Name
- non-sterile cold/warm compress EUDAMED
- Model / Reference
- KCZ7513 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996818020 EUDAMED
- Basic UDI-DI
- 59079968M9001Q6 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Cold/warm compress by ZARYS International Spółka z ograniczoną odpowiedzialnością — 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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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 | 59079968M9001Q6 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED dd94a53d-1331-4c6c-8051-2e437777eb29 61 fields · synced Oct 8, 2026