Identity
- Device Name
- Sterile Filter Drape EUDAMED
- Model / Reference
- 85234007452 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848340018138 EUDAMED
- Basic UDI-DI
- 84834000852348007452PJ EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Filter Drape by Advance Medical Designs, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K934688 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 84834000852348007452PJ | Class I | Active |
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Manufacturer
- Manufacturer
- Advance Medical Designs, Inc.
- EUDAMED SRN
- US-MF-000009790
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 1823e21f-8d87-4e05-97a6-eb3bf3f46f05 61 fields · synced Oct 5, 2026
- FDA 510(k) K934688 1 fields · synced May 18, 2026