Identity
- Trade Name
- Calla Cushion (white) EUDAMED
- Device Name
- Calla Cushion EUDAMED
- Model / Reference
- Calla Cushion EUDAMEDPP1W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033675192758 EUDAMED
- Basic UDI-DI
- 803367519PPV5 EUDAMED
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER 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: Cast/bandage waterproof bathing cover, reusable
Calla Cushion (white) by Qualiteam s.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cast/bandage waterproof bathing cover, 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 | 803367519PPV5 | Class I | Active |
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Manufacturer
- Manufacturer
- Qualiteam s.r.l.
- EUDAMED SRN
- IT-MF-000026616
Sources (1)
- EUDAMED 90977afc-92b7-4bac-ac5c-5a624d34e5da 61 fields · synced Jul 29, 2026