Identity
- Trade Name
- Calla Ear Band EUDAMED
- Device Name
- Calla Ear Band EUDAMED
- Model / Reference
- Calla Ear Band EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033675199641 EUDAMED
- Basic UDI-DI
- 803367519EAT6 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Calla Ear Band by Qualiteam s.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 803367519EAT6 | Class I | Active |
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Manufacturer
- Manufacturer
- Qualiteam s.r.l.
- EUDAMED SRN
- IT-MF-000026616
Sources (1)
- EUDAMED 16608c18-3a6b-47a3-a5ef-03f372f4b323 61 fields · synced Jun 19, 2026