Identity
- Trade Name
- Exacta Hydraulic Pinch Gauge EUDAMED
- Device Name
- Exacta Hydraulic Pinch Gauge EUDAMED
- Model / Reference
- 696 EUDAMEDNC70141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00768627701419 EUDAMED
- Basic UDI-DI
- 0768627REHAB-696-GY EUDAMED
- Direct Marketing DI
- 00768627701419 EUDAMED
- EMDN Code
- Z12062680 DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Exacta Hydraulic Pinch Gauge 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 | 0768627REHAB-696-GY | 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 00c3ff26-72f1-4ca4-b385-8e4fd7e6a01a 61 fields · synced Jul 10, 2026