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Progress Elbow Orthosis Splint, Pediatric
EUDAMEDClass I (EU MDR)
Ref NC25653Model 655
Identity
- Trade Name
- Progress Elbow Orthosis Splint, Pediatric EUDAMED
- Device Name
- Progress Elbow Orthosis EUDAMED
- Model / Reference
- 655 EUDAMEDNC25653 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627007924 EUDAMED
- Basic UDI-DI
- 0768627ORTHO-655-74 EUDAMED
- Direct Marketing DI
- 00768627007924 EUDAMED
- EMDN Code
- Y060619 ELBOW-WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I 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
Progress Elbow Orthosis Splint, Pediatric 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-655-74 | 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 047b419d-4076-48d8-bb07-0200921dc510 61 fields · synced Jun 18, 2026