Identity
- Device Name
- LPDE Camera Cover EUDAMED
- Model / Reference
- PDE120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848340010514 EUDAMED
- Basic UDI-DI
- 84834000PDE120C6 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
LPDE Camera Cover by Advance Medical Designs, Inc. — 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 | 84834000PDE120C6 | 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 (1)
- EUDAMED 19f3ac6f-3c94-4ee4-a28f-0dd788aff74d 61 fields · synced Oct 6, 2026