Identity
- Device Name
- VARISAN ARMSLEEVE EUDAMED
- Model / Reference
- BM2E9-862-4L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053484215325 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
Category: Compression/pressure sock/stocking, reusable
Varisan Armsleeve by Cizeta Medicali S.p.a. — 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 | 8053484ARMSLEEVE_BH | Class I | Active |
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Manufacturer
- Manufacturer
- Cizeta Medicali S.p.a.
- EUDAMED SRN
- IT-MF-000028355
Sources (1)
- EUDAMED a1856c55-9472-4785-8fb9-a25c426a97ec 61 fields · synced Jun 18, 2026