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Norco Elbow/Heel Protectors, XL (PR)
EUDAMEDClass I (EU MDR)
Ref NC58801-4Model 460
Identity
- Trade Name
- Norco Elbow/Heel Protectors, XL (PR) EUDAMED
- Device Name
- Norco Elbow/Heel Protector EUDAMED
- Model / Reference
- 460 EUDAMEDNC58801-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627000178 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-460-6C EUDAMED
- Direct Marketing DI
- 00768627000178 EUDAMED
- EMDN Code
- Y060618 ELBOW-WRIST ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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 Norco Elbow/Heel Protectors, XL (PR) medical device provides an effective and reliable solution for protecting the affected area from excessive friction, pressure, or rubbing. These custom-fit elbow and heel protectors are designed to provide a secure grip, reducing the risk of injury and promoting comfortable movement.
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 | 0768627ORTHO-460-6C | Class I | Active |
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Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED f9f7de59-650b-4333-885b-f4be5c86ea7e 61 fields · synced Jul 24, 2026