Identity
- Device Name
- VARISAN ARMSLEEVE EUDAMED
- Model / Reference
- BP1E9-739-2S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053484215752 EUDAMED
- Basic UDI-DI
- 8053484ARMSLEEVE_BH EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - 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
Varisan Armsleeve by Cizeta Medicali S.p.a. — 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 | 8053484ARMSLEEVE_BH | Class I | Active |
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Manufacturer
- Manufacturer
- Cizeta Medicali S.p.a.
- EUDAMED SRN
- IT-MF-000028355
Sources (1)
- EUDAMED ae3999e6-5a38-4ce2-a32e-a461ba066e17 61 fields · synced Sep 18, 2026