Identity
- Trade Name
- Hot Cold Pack (Cold Sleeve) EUDAMED
- Device Name
- Hot Cold Pack (Cold Sleeve) EUDAMED
- Model / Reference
- FM-461K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942272654618 EUDAMED
- Basic UDI-DI
- 69422726P4.09.01Z5 EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
Hot Cold Pack (Cold Sleeve) by FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69422726P4.09.01Z5 | Class I | Active |
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Manufacturer
- Manufacturer
- FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
- EUDAMED SRN
- CN-MF-000009645
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 472f4aaf-9a6c-42b7-bfbd-419caa6cf83d 61 fields · synced Oct 7, 2026