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Prima - Adjustable-Width Shoes - Black- Size 37
EUDAMEDClass I (EU MDR)
Ref 494804N37Model PRIMA-NOIR
by Neut
Identity
- Trade Name
- PRIMA - ADJUSTABLE-WIDTH SHOES - BLACK- SIZE 37 EUDAMED
- Model / Reference
- PRIMA-NOIR EUDAMED494804N37 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664588003807 EUDAMED
- Basic UDI-DI
- 3664588PRIMA0093 EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
The PRIMA - Adjustable-Width Shoes are a medical device designed to provide comfort and support for patients undergoing various procedures, including sterilization, surgery, and implantation. This adjustable-width shoe model is ideal for use in a variety of settings, from operating rooms to patient recovery areas.
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 | 3664588PRIMA0093 | Class I | Active |
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Manufacturer
- Manufacturer
- Neut
- EUDAMED SRN
- FR-MF-000009582
Sources (1)
- EUDAMED cda6a4dc-d6fb-40b3-8b2a-f75319506a6e 61 fields · synced Jul 26, 2026