Identity
- Trade Name
- BIGtrack 2 EUDAMED
- Device Name
- BIGtrack 2 EUDAMED
- Model / Reference
- 12000006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00186648000340 EUDAMED
- Basic UDI-DI
- 018664800012000006WL EUDAMED
- Direct Marketing DI
- 00186648000340 EUDAMED
- EMDN Code
- Y210906 MOUSE AND KEYBOARD EMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
BIGtrack 2 by AbleNet 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 | 018664800012000006WL | Class I | Active |
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Manufacturer
- Manufacturer
- AbleNet Inc.
- EUDAMED SRN
- US-MF-000008722
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (1)
- EUDAMED fef9e8dc-be17-4016-8d12-3d518eff6242 61 fields · synced Jul 9, 2026