← Back to catalogue
Norco Gel Elbow/Heel Protectors, MD (PR)
EUDAMEDClass I (EU MDR)
Ref NC58800-2Model 460
Identity
- Trade Name
- Norco Gel Elbow/Heel Protectors, MD (PR) EUDAMED
- Device Name
- Norco Elbow/Heel Protector EUDAMED
- Model / Reference
- 460 EUDAMEDNC58800-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627000116 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-460-6C EUDAMED
- Direct Marketing DI
- 00768627000116 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
Norco Gel Elbow/Heel Protectors, MD (PR) by North Coast Medical, 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 | 0768627ORTHO-460-6C | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- North Coast Medical Inc.
- EUDAMED SRN
- US-MF-000009087
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 8ef9153a-4a08-4116-be1d-095ad397cf67 61 fields · synced Jul 15, 2026